Document Number DL-CF-SL-T-01-102

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TECHNICAL
DOCUMENTATION
(acc. to MDR (EU) 2017/745 Annex II & III)

Product: Latex Examination Gloves, Powder Free, Chlorinated,

Non-Sterile/Sterile/Sterile, EU Spec,
Medical Grade Product Group Code: DLCF

Revision: 06
Date: 25 July 2024

PREPARED BY: APPROVED BY:

Mr. Nattawut Promthong Mr. Daniel Stocker
Senior Assistant Technical Product Group of Quality and R&D Manager
Management

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SIGNED: SIGNED:
Electronic file is valid without a signature Electronic file is valid without a signature

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TABLE OF CONTENTS

Contents Page

1. Device description and specification, including variants and accessories 3

2. Information to be supplied by the manufacturer 21

3. Design and manufacturing information 23

4. General safety and performance requirements 35

5. Benefit-risk analysis and risk management 35

6. Product verification and validation 37

7. Post-market surveillance 44

8. Reference 49

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TECHNICAL DOCUMENTATION
1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
1.1 Device description and specification

(a) Product or trade name and a general description of the device including its intended purpose and intended
users

Product or Trade Name

Latex Examination Gloves, Powder Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade

Product Group Code

DLCF

Legal Manufacturer
Sri Trang Gloves (Thailand) Public Company Limited
10 Soi 10, Phetkasem Road, Hat Yai, Songkhla 90110 Thailand

Manufacturing Facilities
Site 1 (STGT-HY1): 110 Kanjanavanit Road, Pahtong, Hat Yai, Songkhla 90230 Thailand
Site 2 (STGT-HY2): 109/2 Kanjanavanit Road, Pahtong, Hat Yai, Songkhla 90230 Thailand Site
3 (STGT-HY3): 352 Kanjanavanit Road, Pahtong, Hat Yai, Songkhla 90230 Thailand Site
4 (STGT-HY4): 110/3 Kanjanavanit Road, Pahtong, Hat Yai, Songkhla 90230 Thailand Site 5
(STGT-SR): 189 Moo 7, Phlai Wat, Kanchanadit, Surat Thani 84160 Thailand
Site 6 (STGT-TG): 85 Moo 6, Kuan Thani, Kantang, Trang 92110 Thailand

European Authorised Representative

Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany

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Table 1: General Description

NO. Topic Description

1 Product name Latex Examination Gloves, Powder Free, Chlorinated, Non-
Sterile, EU Spec, Medical Grade
2 Product group code DLCF
3 Product code DLCFSLT
DLCFSLT
4 Product specification code DLCFSLT -S-EU-M-NS 80 pack
DLCFSLT -B-EU-M-NS 100 pack
5 Type Single-use disposable examination glove
6 Marking All information on dispenser box
7 Shape Ambidextrous
8 Material Natural rubber latex
9 Inner treatment Online Chlorination
10 Outer treatment No treatment
11 Cuff/ surface Rolled cuff/ Textured at finger tip
12 Color Pale Yellow, the color may vary due to storage time and
conditions.
13 Available sizes Extra Small (XS)
Small (S)
Medium (M)
Large (L)
Extra Large (XL)

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NO. Topic Description

14 Photographs

Figure 1: Photograps of DLCF product

Intended Purpose
A patient examination glove is a disposable device intended for medical purposes that is worn on the
examiners hand or finger to prevent contamination between patient and examiner. Latex Examination Gloves,
Powder Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF) are intended for
medical activities except surgery.

Intended Users
Medical personnel, who perform medical examinations, diagnostic and therapeutic procedures, as well as
personnel, who work with contaminated medical materials.

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(b) The Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in
question, as soon as identification of this device becomes based on a UDI system, or otherwise a clear
identification by means of product code, catalogue number or other unambiguous reference allowing
traceability

The Basic UDI-DI of Latex Examination Gloves, Powder Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU
Spec, Medical Grade (DLCF) is 8859130619260.

The definition is as follows:

88591306: Company Prefix registered number with GS1 represents for Sri Trang Gloves (Thailand) Public
Company Limited
DLCF: Product Reference as Latex Examination Gloves, Powder Free, Chlorinated, Non-
Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF)
V9: Check Character that has been calculated and validated on GS1 website

(c) The intended patient population and medical conditions to be diagnosed, treated and/or monitored and
other considerations such as patient selection criteria, indications, contraindications, warnings

Intended Patient Population

The intended patient population is for medical personnel, who perform medical examinations, diagnostic and
therapeutic procedures, as well as personnel, who work with contaminated medical materials.

Examination gloves are intended for all kind of patients, with the requirement of hygienic medical therapy
and/or examination, both superficial skin and natural body orifices. It is not intended for patients, that require
surgical procedures. Respective sensitizations and allergy warnings must be respected.

Medical Conditions to be Diagnosed, Treated and/or Monitored

The examination gloves are used in medical or healthcare facilities indoors in a dry place, away from direct
sunlight, at recommended temperature from 10 °C to 30 °C.
The examination gloves are intended for medical activities except surgery.

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Indications
The indications for use of the medical device are the necessity of conduction of medical examinations,
diagnostic and therapeutic procedures.

Table 2: Summary of the Indications for Gloving and for Glove Removal
Indication
Gloves on 1) Before hygienic procedures
2) When anticipating contact with blood or another body fluid, regardless
of the existence of sterile conditions and including contact with non-intact
skin and mucous membrane
3) Contact with a patient (and his/her immediate surroundings) during
contact precautions
Gloves off 1) As soon as gloves are damaged (or non-integrity suspected)
2) When contact with blood, another body fluid, non-intact skin and
mucous membrane has occurred and has ended
3) When contact with a single patient and his/her surroundings, or a
contaminated body site on a patient has ended
4) When there is an indication for hand hygiene
5) When healthcare facility internal guidelines require the removal of the
glove

Contraindications/ Warning

The contraindications/ warning of the examination gloves are as follows:

 For single use only;
 For individual use only;
 It is necessary to perform hygienic treatment of your hands before putting on or changing gloves, as
well as after removing the gloves;
 It is necessary to choose the gloves of the right size;
 It is necessary to change the gloves in case of any defect, puncture, damage, contamination, etc.;
 It is necessary to put the gloves on dry hands only;
 Keep in dry condition and avoid the sunlight or other ozone sources;
 The composition of the medical device includes natural rubber latex that may cause an allergic
reaction
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(d) Principles of operation of the device and its mode of action, scientifically demonstrated if necessary

A patient examination glove is a disposable device intended for medical purposes that is worn on the
examiners hand or finger to prevent contamination between patient and examiner. Latex Examination Gloves,
Powder Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF) are intended for
medical activities except surgery.

The operational principles might vary, depending on healthcare facilities and operations done with the
product. The usage procedure is self-explanatory and further instructed during the training of healthcare
personnel. The general contradictions and warnings apply to all procedures.

(e) The rationale for the qualification of the product as a device

Medical gloves are used to prevent the transmission of disease and provide a safety barrier against
contamination. They are typically used during examinations or medical procedures. As such, they are medical
devices.

(f) The risk class of the device and the justification for the classification rule(s) applied in accordance with
Annex VIII

Latex Examination Gloves, Powder Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical

Grade (DLCF) are medical device, class I.
The product is classified in accordance with Rule 1 and Rule 5 of Annex VIII;

“Rule 1: All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies”
“Rule 5: All invasive devices with respect to body orifices, other than surgically invasive devices, which are
not intended for connection to an active device or which are intended for connection to a class I active device are
classified as: Class I if they are intened for transient use”.

The rationale for classification is shown as table below.

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Table 3: Classification Rationale

Classification Rules Applicable Rationale
Acc. to Annex VIII (Y/N)
Non-invasive devices, Y The examination gloves are disposable device intended for
Rule 1 medical purposes that are worn on the examiners hand or
finger to prevent contamination between patient and
examiner. Examination gloves are intended for medical
activities except surgery and mostly used for external, so it
could be determined that the device is non-invasive as class
I.
Non-invasive devices, N The examination gloves are not intended for channelling or
Rule 2 storing blood, body liquids, cells or tissues, liquids or gases
for the purpose of eventual infusion, administration or
introduction into the body.
Non-invasive devices, N The examination gloves are not intended for modifying the
Rule 3 biological or chemical composition of human tissues or cells,
blood, other body liquids or other liquids intended for
implantation or administration into the body.
Also the examination gloves are not consisted of a substance
or a mixture of substances intended to be used in vitro.
Non-invasive devices, N The examination gloves are not intended for come into
Rule 4 contact with injured skin or mucous membrane.
Invasive devices, Y The examination gloves are also intended for transient use in
Rule 5 term of invasive device with respect to body orifices such as
gynecologist or dental work.
Invasive devices, N The examination gloves are intended for medical activities
Rule 6 - 8 except surgery, so the device is not classified as surgically
invasive devices as well as implantable devices.
Active devices, N A patient examination glove is a disposable device intended
Rule 9 - 13 for medical purposes that is worn on the examiners hand or
finger to prevent contamination between patient and
examiner, so the device is not classified as active devices.

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Classification Rules Applicable Rationale

Acc. to Annex VIII (Y/N)
Special rule 14 N A patient examination glove is a disposable device
intended for medical purposes that is worn on the
examiners hand or finger to prevent contamination
between patient and examiner, so the device is not
classified as medicinal product.
Special rule 15 N The examination gloves are not intended to use for
contraception or prevention of the transmission of
sexually transmitted diseases.
Special rule 16 N The examination gloves are not intended
specifically to be used for disinfecting, cleaning,
rinsing or, where appropriate, hydrating contact
lenses.
Also the examination gloves are not intended
specifically to be used for disinfecting or sterilizing
medical devices.
Special rule 17 N The examination gloves are not intended
specifically for recording of diagnostic images
generated by X-ray radiation.
Special rule 18 N The examination gloves are not manufactured
utilising tissues or cells of human or animal origin,
or their derivatives, which are non-viable or
rendered non-viable.
Special rule 19 N The examination gloves are not incorporating or
consisting of nanomaterial.
Special rule 20 N The examination gloves are not intended as invasive
devices with respect to body orifices to administer
medicinal products by inhalation.

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Classification Rules Applicable Rationale

Acc. to Annex VIII (Y/N)
Special rule 21 N A patient examination glove is a disposable device
intended for medical purposes that is worn on the
examiners hand or finger to prevent contamination
between patient and examiner. The examination
gloves are intended for medical activities except
surgery, so the device is not composed of
substances or of combinations of substances that
are intended to be introduced into the human body
via a body orifice or applied to the skin and that are
absorbed by or locally dispersed in the human body.
Special rule 22 N A patient examination glove is a disposable device
intended for medical purposes that is worn on the
examiners hand or finger to prevent contamination
between patient and examiner, so the device is not
classified as active therapeutic devices.

(g) An explanation of any novel features

This requirement is not applicable, as examination gloves are not claimed as novel devices.

(h) A description of the accessories for a device, other devices and other products that are not devices, which
are intended to be used in combination with it

This requirement is not applicable, as examination gloves are not worn with other accessories or used in
combination.

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(i) A description or complete list of the various configurations/variants of the device that are intended to be
made available on the market

The examination gloves will be packed and made available on the market under form of its packaging.

The package provides protection from the exposure to mechanical and climatic factors during transportation
and storage. The package consists of primary and secondary packaging as follows;

Primary packaging or Dispenser box: The gloves are packed into dispenser box. The dispenser box provides
protection of gloves from external mechanical damage and makes it possible to determine visually the
identification and traceability of the gloves.
Secondary packaging or Transport carton: The dispenser boxes are packed into transport carton. Transport
carton boxes are strong enough and provide safety of devices during transportation and storage.

Therefore, a description or complete list of the various configurations/variants of the device that are intended
to be made available on the market is shown as table below.

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Table 4: Complete List of the Various Configurations/Variants of the Device

NO. Topic Description
1 Glove sizes Available sizes
Extra Small (XS)
Small (S)
Medium (M)
Large (L)
Extra Large (XL)

Dimension: hand-width
XS: < 80 mm
S: 80 ± 10 mm
M: 95 ± 10 mm
L: 110 ± 10 mm
XL: > 110 mm

Dimension: length
Median 240 mm for all sizes

Dimension: double wall thickness

Finger: Min 0.16 mm
Palm: Min 0.16 mm
2 Glove packing sizes The quantity of packing/packages shall follow the agreed
specification for each brand, according to SCT.QA.FO.15.011
Approbation – Approval Packaging & Labels that could be variant
quantity as the following samples;
 Gloves are packed 100 pcs into each dispenser box, then 10
dispenser boxes are packed into each transport carton

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NO. Topic Description

3 Packaging sizes Pack 100 pcs per each dispenser box, then pack 10 dispenser boxes
per each transport carton, the dimension is as follows:

Dispenser Box
Packaging code: PKGPF02
Width: 122 mm
Length: 240 mm
Height: 65 mm
Weight: 58 g

Transport Carton
Packaging code: PKGPF02
Width: 249 mm
Length: 340 mm
Height: 250 mm
Weight: 271 g

4 Packaging materials Dispensor box: Duplex Paper

Transport carton: Brown Craft Paper (B-Flute)

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(j) A general description of the key functional elements, e.g. its parts/components (including software if
appropriate), its formulation, its composition, its functionality and, where relevant, its qualitative and
quantitative composition. Where appropriate, this shall include labelled pictorial representations (e.g.
diagrams, photographs, and drawings), clearly indicating key parts/components, including sufficient
explanation to understand the drawings and diagrams

Table 5: General Description of the Key Functional Elements

NO. Topic Description
1 General description of the key Latex Examination Gloves, Powder Free, Chlorinated, Non-
functional elements Sterile, EU Spec, Medical Grade (DLCF) are made of natural
latex and chemicals.
To compensate for the lack of powder, the powder free
examination gloves are either subjected to online or offline
chlorination.
In general, online chlorination is a finishing method for
powder free gloves. The gloves are washed in a chlorine
solution. The solution reduces the surface tackiness of the
gloves and also gives it a softer texture allowing for gloves to
be easily donned without powder. When used on latex, the
chlorination process also reduces the amount of latex
proteins, to make them less likely to cause an allergy.
2 Photographs

Figure 2: Photograps of DLCF product

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NO. Topic Description

3 Drawing

Figure 3: Designation of length (d) and width (c) of gloves

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The list of materials/compositions used for the manufacturing of Latex Examination Gloves, Powder Free,
Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF) is shown in table below:

Table 6: Material Used During Manufacturing of the Product

No. Material/Component Function CAS Number

1 Natural Rubber Latex Main Raw Material N/A
2 Sulphur Vulcanizing Agent 7704-34-9
3 Dithiocarbamate Accelerator 14324-55-1, 136-23-2
4 Polymeric Sterically Hindered Phenol Antioxidant 68610-51-5
5 Zinc Oxide Activator 1314-13-2
6 Titanium Dioxide Pigment 13463-67-7
7 Potassium Hydroxide Stabilizer 1310-58-3
8 Calcium Carbonate Additive 1317-65-3

(k) A description of the raw materials incorporated into key functional elements and those making either direct
contact with the human body or indirect contact with the body, e.g., during extracorporeal circulation of body
fluids

Refer to Table 6: Material Used During Manufacturing of the Product.

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(l) Technical specifications, such as features, dimensions and performance attributes, of the device and any
variants/configurations and accessories that would typically appear in the product specification made
available to the user, for example in brochures, catalogues and similar publications

Table 7: Technical Specifications (Quality Characteristics)

Description Specification Test-Method

BARRIER PROPERTIES

Freedom from holes AQL < 1.5 EN 455-1

BIOCOMPATIBILITY

Powder residue on powder free < 2.0 mg/glove EN ISO 21171

gloves < 50 µg/g Monitoring follows EN 455-3
Total Proteins
PHYSICAL PROPERTIES EN 455-2

Force at break (during shelf life) Median 6.0 N EN 455-2

Tensile strength before/ after aging Min 18 MPa / 14 MPa ASTM D 412/ ASTM D 573
Ultimate elongation before/ after Min 650% / 500% ASTM D 412/ ASTM D 573
aging
DIMENSION EN 455-2 EN 455-2

Hand-width size related Size related table issued on

request
XS: < 80 mm
S: 80 ± 10 mm
M: 95 ± 10 mm
L: 110 ± 10 mm
XL: > 110 mm
Total length EN 455-2 EN 455-2
Median 240 mm for all sizes

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Description Specification Test-Method

Double Wall Thickness ASTM D 3578 ASTM D 3767
(not specify spec in EN 455-2)

Finger Min 0.16 mm

Palm Min 0.16 mm

Performance Requirements for Quality Characteristics

 The sampling plan for in-process and final inspection follows in accordance with ISO 2859-1
“Sampling procedures for inspection by attributes – Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection;
 The Acceptance Quality Level shall conform to the AQL mentioned in agreed specification document
“Technical Product Description”
 The product meets the provision of MDR (EU) 2017/745 Class I and the latest revision of EN 455 all
parts.

Brochures and Catalogues

Refer to the below link:
https://www.sritranggloves.com/storage/download/factsheet/20190913-stgt-factsheet-en.pdf

Website:
Refer to the below link:
www.sritranggloves.com

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1.2. Reference to previous and similar generations of the device

(a) An overview of the previous generation or generations of the device produced by the manufacturer, where
such devices exist

Table 8: Overview of Generations of the Device Produced by the Manufacturer

Generation Description of Generations Product

1 Latex Examination Gloves, Powder Free, Offline Latex Examination Gloves,
Chlorination with Turning Process, Non-Sterile/Sterile/Sterile Powder Free
 Inner treatment: offline chlorination (does not exist anymore)
 Outer treatment: no treatment
2 Latex Examination Gloves, Powder Free, Polymer Coated, Latex Examination Gloves,
Non-Sterile/Sterile/Sterile Powder Free
 Inner treatment: polymer coating
 Outer treatment: offline chlorination
3 Latex Examination Gloves, Powder Free, Chlorinated, Non- Latex Examination Gloves,
Sterile Powder Free
 Inner treatment: online chlorination
 Outer treatment: no treatment

(b) An overview of identified similar devices available on the Union or international markets, where such
devices exist

Table 9: Overview of Identified Similar Devices

No. Similar Device Product

1 Latex Examination Gloves, Powder Free, Polymer Coated, Latex Examination Gloves,
Non-Sterile/Sterile/Sterile Powder Free
 Inner treatment: polymer coating
 Outer treatment: offline chlorination

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2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER

(a) The label or labels on the device and on its packaging, such as single unit packaging, sales packaging,
transport packaging in case of specific management conditions, in the languages accepted in the Member
States where the device is envisaged to be sold

The package labeling and marking of symbols will be shown on both packagings of product as follows;
 Dispenser box: this is a primary packaging that the gloves will be packed into a dispenser box;
 Transport carton: this is a secondary packaging that the dispenser boxes above will be packed into
a transport carton

The package labeling and marking of symbols shall comply with the agreed specification of packaging for each
brand according to SCT.QA.FO.15.011 Approbation – Approval Packaging & Labels as well as in
accordance with the applicable regulations/ standards such as
 EN 1041 Information supplied by the manufacturer of medical devices;
 EN ISO 15223-1 Symbols to be used with medical device labels, labelling and information to be
supplied;
 EN 455-3 Requirements and testing for biological evaluation (item – labelling)

(Reference: procedure refers to SCT.QA.QP.15.004 Packaging and Labeling Control)

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(b) The instructions for use in the languages accepted in the Member States where the device is envisaged to
be sold

The requirement for the instruction for use is not applicable for class I devices as the device can be used safely
without any such instructions, however the recommended instruction for use could be determined as below.

Instruction for Use

1. Always wash hands before putting on gloves and each time you change to a new pair.
2. Take the gloves out from their original box.
3. Select glove appropriate for the task and in your size. Inform yourself prior to the application.
4. Touch only a restricted surface of the glove corresponding to wrist (at the top edge of the cuff).
5. Don the first glove by inserting your hand into the opening and pulling it over by applying a soft pull
by the second hand.
6. Take the second glove with bare hand and touch only a restricted surface of the glove
corresponding to wrist.
7. To avoid touching the skin of the forearm with the gloved hand, turn the external surface of the glove
to be donned on the folded fingers of the gloved hand so there is a good hold on it. Thus, permitting
to glove the second hand by pulling softly with the first gloved hand.
8. Once gloved, hands should not touch anything else that is not defined by indications and conditions
for glove use.
9. Change gloves before beginning a different task to avoid cross contamination.
10. Pinch one glove at the wrist level to remove it, without touching the skin of the forearm, and peel
away from the hand, thus allowing the glove to turn inside out.
11. Hold the removed glove in the gloved hand and slide the fingers of the ungloved hand inside between
the glove and the wrist of the gloved hand. Remove the second glove by rolling it down the hand and
fold the first glove into the outside palm area of the second glove. If done correctly, the user holds a
pack of the outer glove turned inside and out and the contaminated surface of both gloves is within
the package.
12. Discharge the removed gloves and wash hands thoroughly according the respective hygiene
standards.
13. Not intended to be used as a chemical barrier.

The shelf life is normally advised to be three full years. Check the original dispenser instructions for details.

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3. DESIGN AND MANUFACTURING INFORMATION

(a) Information to allow the design stages applied to the device to be understood

The design stages will be followed the steps below:

Figure 4: Design stages

(Reference: procedure refers to SCT.QA.QP.04.001 Design Control)

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(b) Complete information and specifications, including the manufacturing processes and their validation, their
adjuvants, the continuous monitoring, and the final product testing. Data shall be fully included in the
technical documentation

Table 10: Complete Information and Specifications

Description Specification Test-Method

BARRIER PROPERTIES

Freedom from holes AQL < 1.5 EN 455-1

BIOCOMPATIBILITY

Powder residue on powder free < 2.0 mg/glove EN ISO 21171

gloves < 50 µg/g Monitoring follows EN 455-3
Total Proteins
PHYSICAL PROPERTIES EN 455-2

Force at break (during shelf life) Median 6.0 N EN 455-2

Tensile strength before/ after aging Min 18 MPa / 14 MPa ASTM D 412/ ASTM D 573
Ultimate elongation before/ after Min 650% / 500% ASTM D 412/ ASTM D 573
aging
DIMENSION EN 455-2 EN 455-2

Hand-width size related Size related table issued on

request
XS: < 80 mm
S: 80 ± 10 mm
M: 95 ± 10 mm
L: 110 ± 10 mm
XL: > 110 mm
Total length EN 455-2 EN 455-2
Median 240 mm for all sizes

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Description Specification Test-Method

Double Wall Thickness ASTM D 3578 ASTM D 3767
(not specify spec in EN 455-2)

Finger Min 0.16 mm

Palm Min 0.16 mm

Performance Requirements for Quality Characteristics

 The sampling plan for in-process and final inspection follows in accordance with ISO 2859-1
“Sampling procedures for inspection by attributes – Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection;
 The Acceptance Quality Level shall conform to the AQL mentioned in agreed specification document
“Technical Product Description”
 The product meets the provision of MDR (EU) 2017/745 Class I and the latest revision of EN 455 all
parts.

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Manufacturing Process
The manufacturing process for Latex Examination Gloves, Powder Free, Chlorinated, Non-
Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF) is shown as below:

Figure 5: Manufacturing process of DLCF

(Reference: procedure refers to SCT.QA.QP.09.001 Production Control)

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Validation
The validation for Latex Examination Gloves, Powder Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec,
Medical Grade (DLCF) consists of validation plan and validation report which shown as follows:

Validation Plan
(Performance Qualification Protocol of Latex Examination Gloves, Powder Free, Chlorinated, Non-
Sterile/Sterile/Sterile, EU Spec, Medical Grade, DLCF)
Reference: VA.QP.PQ.01.053/a250919

1. Purpose
To establish confidence through appropriate testing that the finished product produced by process of group
line Latex Examination Gloves, Powder Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade
(DLCF) are effective and meet all release requirements for functionality and safety.

2. Scope
This Performance Qualification Protocol is applicable for group line of production process of Latex
Examination Gloves, Powder Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF).

3. Process Description and Principle of Operation

According to manufacturing process flow chart, work instruction of production process for Latex Examination
Gloves, Powder Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF).

4. Requirements for the Process

According to parameter specifications of production process for Latex Examination Gloves, Powder Free,
Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF).

5. Inspection/ Test Method for Measuring the Evaluation Results

According to In-Process and Final Inspection Sampling Plan.

6. Manufacturing Materials, Equipment and Calibration

To ensure the approval of materials, availability of equipment and calibration status.

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7. Acceptance Criteria
The performance qualification for group line of production process of Latex Examination Gloves, Powder
Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF) will be acceptable if fulfilment
of following criteria;
 All process parameters meet specification defined.
 All properties of product meet on requirements.

8. Conclusion
To summarize the conclusion of validation for Performance Qualification of Latex Examination Gloves,
Powder Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF).

9. Established by
Mr. Burin Meethip, Assistant Technical Assurance Manager

10. Reviewed and Approved by

Ms. Nawarat Arunpan, Assessment and Technical Assurance Manager

Validation Report
(Performance Qualification Report of Latex Examination Gloves, Powder Free, Chlorinated, Non-
Sterile/Sterile/Sterile, EU Spec, Medical Grade, DLCF)
Reference: VA.RE.PQ.01.074/a091019

1. Purpose
To establish confidence through appropriate testing that the finished product produced by process of group
line Latex Examination Gloves, Powder Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade
(DLCF) are effective and meet all release requirements for functionality and safety.

2. Scope
This Performance Qualification Protocol is applicable for group line of production process of Latex
Examination Gloves, Powder Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF).

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3. Process Description and Principle of Operation

According to manufacturing process flow chart, work instruction of production process for Latex Examination
Gloves, Powder Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF).

4. Requirements for the Process

According to parameter specifications of production process for Latex Examination Gloves, Powder Free,
Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF).

5. Inspection/ Test Method for Measuring the Evaluation Results

According to In-Process and Final Inspection Sampling Plan.

6. Manufacturing Materials, Equipment and Calibration

The approval of materials, availability of equipment and calibration status, are completed prior validation.

7. Acceptance Criteria
The performance qualification for group line of production process of Latex Examination Gloves, Powder
Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF) will be acceptable if fulfilment
of following criteria;
 All process parameters meet specification defined.
 All properties of product meet on requirements.

8. Conclusion
The performance qualification for group line of production process of Latex Examination Gloves, Powder
Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF) is completed, acceptable and
complied to the following criteria;
 All process parameters meet specifications defined.
 All properties of product meet on requirements.

9. Established by
Mr. Burin Meethip, Assistant Technical Assurance Manager

10. Reviewed and Approved by

Ms. Nawarat Arunpan, Assessment and Technical Assurance Manager

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Quality Assurance Monitoring and the Final Product Testing

Table 11: Quality Assurance Monitoring and the Final Product Testing

No. Quality Assurance Description

Inspection and
Testing
1 Incoming materials This step is to inspect and ensure that the quality of materials include
inspection latex, chemicals, packaging and glove molds meet the specifications
defined of each material.

Figure 6: Flow chart of incoming materials inspection

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No. Quality Assurance Description

Inspection and
Testing
2 Ingredient and This step is to inspect and ensure that the quality of ingredients and
compounding compounds after preparation meet the specifications defined before
preparation approval to use in production line.
inspection

Figure 7: Flow chart of ingredient and compounding preparation inspection

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No. Quality Assurance Description

Inspection and
Testing
3 Production line/ This step is to check and ensure that parameters control in production
chemical in line line meet the specifications defined as well as to inspect and ensure that
inspection the chemicals in production line meet the specifications defined.

Figure 8: Flow chart of chemical in line inspection

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No. Quality Assurance Description

Inspection and
Testing
4 In-process & Final This step is to inspect and ensure that the quality of gloves/ packaging
inspection meet the specifications defined.

Figure 9: Flow chart of in-process & final inspection

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(c) Identification of all sites, including suppliers and sub-contractors, where design and manufacturing
activities are performed

Manufacturing Site Facilities

Sri Trang Gloves (Thailand) Public Company Limited

Site 1 (STGT-HY1): 110 Kanjanavanit Road, Pahtong, Hat Yai, Songkhla 90230 Thailand
(Scope: Design and Development, Production and Distribution of Sterile and Non-Sterile/Sterile/Sterile Examination Gloves)

Site 2 (STGT-HY2): 109/2 Kanjanavanit Road, Pahtong, Hat Yai, Songkhla 90230 Thailand
(Scope: Production and Distribution of Sterile and Non-Sterile/Sterile/Sterile Examination
Gloves)

Site 3 (STGT-HY3): 352 Kanjanavanit Road, Pahtong, Hat Yai, Songkhla 90230 Thailand
(Scope: Production and Distribution of Sterile and Non-Sterile/Sterile/Sterile Examination
Gloves)

Site 4 (STGT-HY4): 110/3 Kanjanavanit Road, Pahtong, Hat Yai, Songkhla 90230 Thailand
(Scope: Production and Distribution of Sterile and Non-Sterile/Sterile/Sterile Examination
Gloves)

Site 5 (STGT-SR): 189 Moo 7, Phlai Wat, Kanchanadit, Surat Thani 84160 Thailand
(Scope: Production and Distribution of Sterile and Non-Sterile/Sterile/Sterile Examination
Gloves)

Site 6 (STGT-TG): 85 Moo 6, Kuan Thani, Kantang, Trang 92110 Thailand

(Scope: Production and Distribution of Sterile and Non-Sterile/Sterile/Sterile Examination Gloves)

Design and development is a centralised function located at address of site 1, to support for all manufacturing
site facilities of Sri Trang Gloves (Thailand) Public Company Limited.

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4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

(a) The general safety and performance requirements that apply to the device and an explanation as to why
others do not apply
(b) The method or methods used to demonstrate conformity with each applicable general safety and
performance requirement
(c) The harmonized standards, CS or other solutions applied
(d) The precise identity of the controlled documents offering evidence of conformity with each harmonised
standard, CS or other method applied to demonstrate conformity with the general safety and performance
requirements. The information referred to under this point shall incorporate a cross-reference to the location
of such evidence within the full technical documentation and, if applicable, the summary technical
documentation

(Reference: SCT.QA.FO.02.008 General Safety and Performance Requirements Checklist, Latex Powder Free
Examination Gloves, Non-Sterile/Sterile/Sterile)

5. BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT

(a) The benefit-risk analysis referred to in Sections 1 and 8 of Annex I

Based on the conducted risk analysis for the Latex Examination Gloves, Powder Free, Non-
Sterile/Sterile/Sterile product, the foreseeable risks have been identified and evaluated in most cases as
acceptable with respect to the intended application and use of the products. Counteractions have been taken
for those items for which an initially unacceptable risk has been identified. Subsequently, the performed
implementations were verified. Finally, it can be determined that no unacceptable residual risk exists with the
products either individually or cumulatively, that outweighs the benefits from the use of the products.

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(b) The solutions adopted and the results of the risk management referred to in Section 3 of Annex I

Based on the conducted risk analysis for the Latex Examination Gloves, Powder Free, Non-
Sterile/Sterile/Sterile product, the foreseeable risks have been identified and evaluated in most cases as
acceptable with respect to the intended application and use of the products. Counteractions have been taken
for those items for which an initially unacceptable risk has been identified. Subsequently, the performed
implementations were verified. Finally, it can be determined that no unacceptable residual risk exists with the
products either individually or cumulatively, that outweighs the benefits from the use of the products.

(Reference: Risk Management Plan and Risk Analysis Report of Latex Powder Free Examination Gloves, Non-
Sterile/Sterile/Sterile)

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6. PRODUCT VERIFICATION AND VALIDATION

6.1. Pre-Clinical and Clinical Data
(a) Results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of
published literature applicable to the device, taking into account its intended purpose, or to similar devices,
regarding the pre-clinical safety of the device and its conformity with the specifications
(b) Detailed information regarding test design, complete test or study protocols, methods of data analysis, in
addition to data summaries and test conclusions regarding in particular

 The biocompatibility of the device including the identification of all materials in direct or indirect
contact with the patient or user

The biocompatibility tests for Latex Examination Gloves, Powder Free, Chlorinated, Non-
Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF) shown as the following table:

Table 12: Biocompatibility Tests

No. Test Item Reference Test Institute Test Report Summary Result
Standard
1 Cytotoxicity EN ISO 10993-5 Nelson Labs 1156407-S01.1 Grade 0 at dilution 1: 8
No cell lysis,
intracytoplasmic granules
2 Irritation EN ISO 10993- Toxikon 19-02021-G2 The test article sites did
10 not show a significantly
greater biological reaction
than the sites injected with
the control article
3 Skin EN ISO 10993- Toxikon 19-02021-G1 The test article is classified
Sensitization 10 as a non-sensitizer
4 Viral ASTM F 1671 Nelson Labs 1156409-S01.1 Pass, acceptable
Penetration

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 Physical, chemical and microbiological characterisation

The physical, chemical and microbiological characterization tests for Latex Examination Gloves, Powder
Free, Chlorinated, Non-Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF) shown as the following table:

Table 13: Physical, Chemical and Microbiological Characterization Tests

No Test Item Reference Test Institute Test Report Summary

. Standard Result
1 Freedom from EN 455-1 TUV SUD PSB Pte. Ltd. 7191205854-EEC19/01- Pass
holes WBH
2 Dimension EN 455-2 TUV SUD PSB Pte. Ltd. 7191205854-EEC19/02- Pass
WBH
3 Tensile EN 455-2 TUV SUD PSB Pte. Ltd. 7191205854-EEC19/03- Pass
WBH
4 Protein EN 455-3 Lembaga Getah LGM/BTK/UPB/5.10/CP/18 Pass
04/0169
5 Residual EN 455-3 TUV SUD PSB Pte. Ltd. 7191205854-CHM19-JS- Pass
Powder 05

 Electrical safety and electromagnetic compatibility

This requirement is not applicable, as examination gloves are not relating to electrical safety and
electromagnetic compatibility.

 Software verification and validation

This requirement is not applicable, as software is not used in finished devices – examination gloves.

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 Stability, including shelf life

The stability, including shelf life test for Latex Examination Gloves, Powder Free, Chlorinated, Non-
Sterile/Sterile/Sterile, EU Spec, Medical Grade (DLCF) shown as the following table:

Table 14: Stability and Shelf Life Test

No Test Item Reference Test Institute Test Report Summary Result

. Standard
1 Stability and EN 455-4 In-house testing STGTSR-SL-19- Based on conducted the
Shelf Life 004 stability study, the real
time shelf life for Latex
Examination Gloves,
Powder Free,
Chlorinated, Non-
Sterile/Sterile/Sterile, EU
Spec, Medical Grade
(DLCF) is up to 5 years

 Performance and safety

Design Validation
The design of this product has been validated to ensure the performance and safety of examination gloves
according to the following evaluation items:
 Fit/ comfort
 Skin irritation
 Tactile sensitivity (dry, wet)
 Grip
 Ease of donning
 Odor

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 Color
 Strength/ durability
Summary: the result of design validation is acceptable.

(Reference: procedure refers to SCT.QA.QP.04.001 Design Control)

Packaging Verification
The packaging is also verified the performance and safety to ensure that the package are strong enough and
and provided safety of devices during transportation and storage.

The box compression test (BCT) to the package shown as the following:

Table 15: Box Compression Test of Packaging

Product Package BCT Requirement (Kgf) BCT Results (Kgf)
L001 Pack 100 glove pcs per dispenser 269.9 332.8
box, 10 dispenser boxes per carton

(c) The clinical evaluation report and its updates and the clinical evaluation plan referred to in Article 61(12)
and Part A of Annex XIV

Conclusion of Clinical Evaluation

The clinical evaluation clearly demonstrates that the Latex Examination Gloves, Powder Free, Non-
Sterile/Sterile/Sterile are in conformity with the relevant general safety and performance requirements of MDR
2017/745 (Annex I) by compliance to the requirements of EN 455. The current information material is
considered adequate with respect to the intended user.

The performance and safety of Latex Examination Gloves, Powder Free, Non-Sterile/Sterile/Sterile have been
established and risk associated with the use of these devices are acceptable when weighed against the
benefits to the patient.

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Taken together, the performance and safety of the devices have been established and risks associated with
the use of the devices are acceptable when weighed against the benefit for the user and patient.

(Reference: Clinical Evaluation Report, Examination Gloves, Non-Sterile/Sterile/Sterile)

(d) The PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a
PMCF is not applicable

The PMCF Plan outlines the methods and chosen frames for updating the clinical evaluation on a regular
basis, incorporating new sources of information and checking on identified risks and the correct assessment
of those in the risk management activities.

Examination gloves, both sterile and Non-Sterile/Sterile/Sterile, are used since centuries and the materials NBR and
NR have been well established with several hundred billion gloves per year consumed all over the world. From
this fact and the current post-market surveillance data available, there might be the possibility explored, that
PMCF studies are not necessary to evaluate the safety, quality or performance of that particular medical
devices.

(Reference: Post-Market Clinical Follow-up Plan)

6.2. Additional Information Required in Specific Cases

(a) Where a device incorporates, as an integral part, a substance which, if used separately, may be considered
to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a
medicinal product derived from human blood or human plasma, as referred to in the first subparagraph of
Article 1(8), a statement indicating this fact. In this case, the documentation shall identify the source of that
substance and contain the data of the tests conducted to assess its safety, quality, and usefulness, taking
account of the intended purpose of the device

This requirement is not applicable, as examination gloves are not classified as medicinal product devices.

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(b) Where a device is manufactured utilizing tissues or cells of human or animal origin, or their derivatives, and
is covered by this Regulation in accordance with points (f) and (g) of Article 1 (6, and where a device
incorporates, as an integral part, tissues or cells of human origin or their derivatives that have an action
ancillary to that of the device and is covered by this Regulation in accordance with the first subparagraph of
Article 1 (10), a statement indicating this fact. In such a case, the documentation shall identify all materials of
human or animal origin used and provide detailed information concerning the conformity with Sections 13.1.
or 13.2., respectively, of Annex I.

This requirement is not applicable, as examination gloves are not manufactured utilizing tissues or cells of
human or animal origin, or their derivatives.

(c) In the case of devices that are composed of substances or combinations of substances that are intended
to be introduced into the human body and that are absorbed by or locally dispersed in the human body,
detailed information, including test design, complete test or study protocols, methods of data analysis, and
data summaries and test conclusions

This requirement is not applicable, as examination gloves are not composed of substances or combinations of
substances that are intended to be introduced into the human body and that are absorbed by or locally
dispersed in the human body.

(d) In the case of devices containing CMR or endocrine-disrupting substances referred to in Section 10.4.1 of
Annex I, the justification referred to in Section 10.4.2 of that Annex

This requirement is not applicable, as examination gloves do not contain of CMR or endocrine-disrupting
substances.

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(e) In the case of devices placed on the market in a sterile or defined microbiological condition, a description
of the environmental conditions for the relevant manufacturing steps. In the case of devices placed on the
market in a sterile condition, a description of the methods used, including the validation reports, with respect
to packaging, sterilization, and maintenance of sterility. The validation report shall address bioburden testing,
pyrogen testing and, if applicable, testing for sterilant residues

This requirement is not applicable, as this kind of examination gloves is Non-Sterile/Sterile/Sterile and do not define
microbiological condition.

(f) In the case of devices placed on the market with a measuring function, a description of the methods used
in order to ensure the accuracy as given in the specifications

This requirement is not applicable, as examination gloves are not classified as measuring function devices.

(g) If the device is to be connected to other device(s) in order to operate as intended, a description of this
combination/configuration including proof that it conforms to the general safety and performance
requirements when connected to any such device(s) having regard to the characteristics specified by the
manufacturer

This requirement is not applicable, as examination gloves are not to be connected to other devices in order
to operate as intended.

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TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE

1.1. The post-market surveillance plan drawn up in accordance with Article 84

Post-Market Surveillance Plan

The post-market surveillance (PMS) is the activities carried out to gain information about the quality, safety
or performance of medical devices that have been placed in the market.

The post-market surveillance and action system consists of four main steps as follows:

 Step 1 Surveillance Input

The surveillance input is a channel to gain information about the quality, safety or performance of medical
devices that have been placed in the market, which could be determined as the table below.

Table 16: Plan & Time Schedule

NO. Action Timeframe Desired Outcome
1 Without undue delay
Complaint analysis after incoming Proper case studies and statistics
complaint information
2 Comparison & studying of advancement of
Competitor analysis At least once a year
state of the art
3 Proper literature section in the clinical
Literature review At least all two years
evaluation report
4 Interviews with users,
During trade shows, Advanced understanding of changed
customers, conferences,
fairs, customer visits settings, applications, experiences,
regulators and notified
and inspections complaints, technologies and regulations
bodies
5 Without undue delay
after receiving an
Review of authority
authority reports or
reports & actions taken by Learnings from case studies
learning about an
regulators
action taken by a
regulatory

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NO. Action Timeframe Desired Outcome

6 Review of public incident
Once a year Learnings from case studies
reporting databases
Preclinical assessments shall help to study
7 Preclinical Data & Testing Per Demand product performances under standardized
and objective settings.
Raising the level of understanding and
8 Once a quarter awareness on customer side & getting
Proactive questionnaires
(starting with Q3 2020) feedback on more complex and rare product
deficiencies

 Step 2 Investigation & Analysis

After receiving the post-market surveillance information above, the person in charge and all involved in each
PMS topic above shall perform investigate and analysis those information as well as to find and summarize
the investigation and analysis output for further action and communication.

 Step 3 Action
The action shall be taken following the output from investigation and analysis in order to monitor and maintain
the quality, safety or performance of medical devices. Include the action shall comply with the applicable
standards, regulations and laws in each market.
Example of action; response of complaint investigation, adverse event reporting, advisory notice issuing,
recall/ correction and removal, corrective action and prevention action; process, design, labeling, training, and
so on.

 Step 4 Communication
Together with action shall be considered for communication also. The communication shall comply with the
applicable standards, regulations and laws in each market.
Example of communication; to communicate to Stakeholders, Regulatory Authorities, Representative,
Notified Body, Customers, Distributors, Suppliers and so on.

The overall meeting for post-market surveillance (PMS) will be performed at least once a year to summarize
the overall feedback through the year in order to ensure the products are still under safety, quality and
performance of medical devices.

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(Reference: procedure refers to SCT.QA.QP.19.001 Feedback, Post-Market Clinical Follow-up Plan)

1.2. The PSUR referred to in Article 86 and the post-market surveillance report referred to in
Alticle 85

Regarding the post-market surveillance, Sri Trang Gloves (Thailand) Public Company Limited has appropriate
procedures in place to handle feedback from the market, the last overall meeting for post-market surveillance
(PMS) could be determined the output from a meeting as follows.

Table 17: Post-Market Surveillance Report

NO. Action Timeframe Report
1 Proper case studies and statistics
“The determined complaint rates reside in a
Without undue delay general accepted level, there is no critical
after incoming compaints concerning alleged deficiencies
Complaint analysis
complaint related to safety or performance that require to
information recall or withdrawal the products from the
market, there is no competent authority post
market surveillance inquiries”
2 Comparison & studying of advancement of
state of the art
Competitor analysis At least once a year “The determined competitor analysis shows
the comparison and studying of competitors
for improvement process”
3 Proper literature section in the clinical
evaluation report
“The determined literature reviews show the
Literature review At least all two years
studying of literature for improvement process
and proper literature section in the clinical
evaluation report”

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NO. Action Timeframe Report

4 Advanced understanding of changed settings,
applications, experiences, complaints,
technologies and regulations
Interviews with users,
During trade shows, “The determined interviews with users,
customers, conferences,
fairs, customer visits customers, conferences, regulators and
regulators and notified
and inspections notified bodies show advanced understanding
bodies
of changed settings, applications,
experiences, complaints, technologies and
regulations”
5 Review of authority Without undue delay Learnings from case studies
reports & actions taken by after receiving an “The determined review of authority reports &
regulators authority reports or actions taken by regulators show thr learnings
learning about an from case studies for improvement process”
action taken by a
regulatory
6 Review of public incident Once a year Learnings from case studies
reporting databases “The determined review of public incident
reporting databases shows thr learnings from
case studies for improvement process”
Preclinical Data & Testing Per Demand Preclinical assessments shall help to study
7 product performances under standardized and
objective settings.
“The determined preclinical data & testing
shows all product performances meet the
standardized and objective settings”
Proactive questionnaires Once a quarter Raising the level of understanding and
8 (starting with Q3 awareness on customer side & getting
2020) feedback on more complex and rare product
deficiencies
“Based on the feedback on the proactive
questionnaire regarding the irritation of gloves,
all feedback received confims that there is no
the case of irritation”
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Therefore, from a meeting, it could be determined that the products are still under safety, quality and
performance of medical devices.

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REFERENCES

Table 18: List of Applicable Regulations and Standards

No. Regulation/ Standard Number Regulation/ Standard Name

1 MDR (EU) 2017/745 Medical Device Regulation
2 PPE (EU) 2016/425 Personal Protective Equipment Regulation
3 ISO 13485: 2016 Medical devices - Quality management systems -
Requirements for regulatory purposes
4 ISO 9001: 2015 Quality management systems – requirements
5 ISO 14971: 2019 Medical devices - application of risk management to
medical devices
6 EN 455-1: 2020 Requirements and testing for freedom from holes
7 EN 455-2: 2015 Requirements and testing for physical properties
8 EN 455-3: 2015 Requirements and testing for biological evaluation
9 EN 455-4: 2009 Requirements and testing for shelf life determination
10 ISO 10993-1: 2018 Biological evaluation of medical devices – Part 1:
Evaluation and testing within a risk management process
11 ISO 10993-5: 2009 Biological evaluation of medical devices – Part 5: Test for
in vitro cytotoxicity
12 ISO 10993-10: 2010 Biological evaluation of medical devices – Part 10: Test
for irritation and skin sensitization
13 ASTM F1671: 2013 Standard test method for resistance of materials used in
protective clothing to penetration by blood-borne
pathogens using phi-x174 bacteriophage penetration as
a test system
14 ASTM D3578: 2019 Standard specification for rubber examination gloves
15 EN 1041: 2008+A1: 2013 Information supplied by the manufacturer of medical
devices
16 EN ISO 15223-1: 2016 EN ISO 15223-1 Symbols to be used with medical device
labels, labelling and information to be supplied
17 ASTM D7160: 2016 Determination of expiration dating for medical gloves

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No. Regulation/ Standard Number Regulation/ Standard Name

18 ASTM D7161: 2016 Determination of real time expiration dating of mature
medical gloves stored under typical warehouse
conditions
19 EN 420: 2003+A1: 2009 Protective gloves - General requirements and test
methods
20 EN ISO 374-1: 2016+A1: 2018 Protective gloves against dangerous chemicals and
micro-organisms - Part 1: Terminology and performance
requirements for chemical risks
21 EN ISO 374-2: 2019 Protective gloves against dangerous chemicals and
micro-organisms - Part 2: Determination of resistance to
penetration
22 EN ISO 374-4: 2019 Protective gloves against chemicals and micro-
organisms - Part 4: Determination of resistance to
degradation by chemicals
23 EN ISO 374-5: 2016 Protective gloves against dangerous chemicals and
micro-organisms - Part 5: Terminology and performance
requirements for micro-organisms risks
24 EN 16523-1: 2015+A1: 2018 Determination of material resistance to permeation by
chemicals - Part 1: Permeation by liquid chemical under
conditions of continuous contact

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