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Nitrile Exam Gloves Powder Free, Standard Cuff: Colloidal Oatmeal System

The document describes a type of nitrile exam glove that contains colloidal oatmeal on the surface. This patented coating forms a natural, moisturizing barrier to protect the skin from irritation. The gloves are powder-free and tested for resistance to permeation by chemotherapy drugs.

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Francisco Garcia
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0% found this document useful (0 votes)
117 views1 page

Nitrile Exam Gloves Powder Free, Standard Cuff: Colloidal Oatmeal System

The document describes a type of nitrile exam glove that contains colloidal oatmeal on the surface. This patented coating forms a natural, moisturizing barrier to protect the skin from irritation. The gloves are powder-free and tested for resistance to permeation by chemotherapy drugs.

Uploaded by

Francisco Garcia
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Colloidal Oatmeal System

Nitrile Exam Gloves


Powder Free, Standard Cuff
GloveOn® COATS® (colloidal oatmeal system) is a patented and
unique nitrile glove technology, which contains an FDA-recognised
skin protectant. These utilise the powerful benefits of all-natural oats
as a coating that forms a natural, moisturising barrier between the
glove and skin. This acts as a preventative measure against
skin irritation and hydration dermatitis. Therefore, users who suffer
from dry and itchy skin can now use GloveOn® COATS® to
LATEX
2 protect their hands while they work.

REORDER CODE
COATS® Nitrile CTS38XXS XX-SMALL
Length (mm) CTS38XS X-SMALL
CTS38SS SMALL
≥ 230
CTS38MM MEDIUM
Thickness Measurements (mm) CTS38LL LARGE
Palm (centre of Palm) 0.07 ± 0.02 CTS38XL X-LARGE

Finger (13mm ± 3mm from tip) 0.09 ± 0.02 FEATURES


Physical Properties Before Ageing After Ageing • Fingertip textured
• Powder free
Tensile Strength (MPa) ≥ 18 ≥ 16
• Not made with natural rubber latex
Elongation (%) ≥ 500 ≥ 400 • Chemo drugs tested
• Lab chemical tested
Inspection Levels & AQL Inspection Level AQL
• Ambidextrous
Watertightness G1 1.5 • Standard cuff
Physical Dimensions S2 4.0 • Dawn blue colour

Tensile Strength S2 4.0 PACKAGING


Visual Inspection (Major) S4 2.5 200 gloves per box for XXS to L
180 gloves per box for XL
Visual Inspection (Minor) S4 4.0
10 boxes per carton
Particulate Residue N=5 ≤ 2mg/glove
Colloidal Oatmeal Content N=5 ≥ 5mg/glove REGULATORY COMPLIANCE
TGA - ARTG 164563, FDA 510(k),
Chemotherapy Drugs and Concentration
EU 2016/425, REACH, EU 10/2011,
Minimum Breakthrough EC 1935/2004, MDD 93/42/EEC
(Tested for Resistance to Permeation by Chemotherapy
Detection Time (minutes)
Drugs as per ASTM D6978-05 Test Report PN 134889A)
Carmustine (BCNU), 3.3mg/ml (3,300 ppm) 21.9 minutes
STANDARDS
ASTM D6319, ASTM D6124,
Cisplatin, 1.0mg/ml (1,000 ppm) >240 minutes
ASTM D5151, ASTM F1671,
Cyclophosphamide (Cytoxan), 20.0mg/ml (20,000 ppm) >240 minutes
EN 455 part 1, 2 & 3, EN 1186,
Dacarbazine (DTIC), 10.0mg/ml (10,000 ppm) >240 minutes EN 13130, CEN/TS 14234, EN 420,
Doxorubicin Hydrochloride, 2.0mg/ml (2,000 ppm) >240 minutes EN 374 part 2, 3, 4 & 5, ISO 16523-1
Etoposide (Toposar), 20.00mg/ml (20,000 ppm) >240 minutes
Fluorouracil, 50.0mg/ml (50,000 ppm) >240 minutes PATENTS
Methotrexate, 25.0mg/ml (25,000 ppm) >240 minutes
Patent 7,691,436; Patent 7,718,240;
Patent 7,740,622; Patent 8,075,965;
Mitomycin C, 0.5mg/ml (500 ppm) >240 minutes
Patent 8,458,818
Paclitaxel (Taxol), 6.0mg/ml (6,000 ppm) >240 minutes
Thiotepa, 10.0mg/ml (10,000 ppm) 36.0 minutes MANUFACTURING ACCREDITATIONS
Vincristine Sulfate, 1.0mg/ml (1,000 ppm) >240 minutes ISO 9001:2015
WARNING: Carmustine and Thiotepa, at the tested concentration, degraded COATS nitrile glove at 21.9 minutes and ISO 13485:2003
36.0 minutes, respectively. The safe use of gloves in chemotherapy treatment is solely the decision of clinicians
authorised to make such decision. EN ISO 13485:2012

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