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Understanding
glove certification
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Understanding
glove certification
Select a glove with the appropriate level of CE certification to
address your application risk and performance requirements
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Look for CE Certification
A notified body gives CE
certification by providing an EC
certificate to PPE Cat III Gloves
To gain a CE marking, protective safety
gloves for sale in Europe must meet a
number of stringent European Standards,
each with its own EN code
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EC type examination
Category 1 Category 2 Category 3
Simple design Intermediate Complex design
design
Technical Documentation
EC quality
control system
for the final
product
EC type-examination
EC declaration of conformity
nnnn
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PPE Category III Gloves :
Complex Design
CE certified to protect against mortal danger and irreversible harm
nnnn
Look for a CE symbol followed by the notified body number
This means that the manufacturing facility is audited and certified and a technical file must
be completed and submitted for EC type Examination by a notified body
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Personal protection
PPE Category III gloves are a minimum
requirement for personal protection in Category III Complex design Medical Device Directive
applications where there is exposure to Gloves EN455
chemicals or micro-organisms. It does 0120
not mean protection against all chemicals Must pass EC type examination
by notified body. For use in
and micro-organisms. Assess the risk and applications where effects are
refer glove performance data for irreversible or mortal risk is
present. Provides protection Are SELF Certified.
EN374-1 and -2 test standards. Not submitted
against microorganism and
chemicals. for EC type examination.
Object is care of the patient
For Personal protection in high
risk applications For Patient protection
Medical Device gloves are self-certified
and are predominantly used for patient Medical Device Directive
Gloves EN455
protection and other medical applications.
This certification provides no standards for
chemical protection. Gloves classified as
medical device only
Are SELF Certified. are not certified for
Not submitted Personal Protection.
for EC type examination.
Object is care of the patient
For Patient protection
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EN Standards
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EN420:2003
Describing general standards for
protective gloves:
• Innocuousness
• Size
• Dexterity
• Package marking
• Instructions for use
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EN374-1:2003 EN374-1:2003
Low chemical protection
(chemical splash protection only)
Gloves offering Low Chemical Protection are suitable for
applications where chemical splash hazards are present.
A chemical splash may still permeate through the glove
and cause harm to the user so only use gloves for which the
manufacturer can provide chemical permeation data for the
particular chemical you are using.
• Consult your glove supplier for chemical
permeation results
• Assess chemical splash risk, refer to each chemical hazard
classification
• Assess maximum exposure time of each specific chemical
• Select a glove with permeation resistance greater than the
exposure time for the specific chemical
EN374-3: 2003 is the test method used to evaluate whether a glove provides chemical protection. For those that do not pass full immersion,
the beaker with the question mark is used to indicate low chemical protection (splash protection only)
Click here to view KIMTECH SCIENCE* Nitrile glove Chemical Permeation Results against 30 of the most common laboratory chemicals
For more information on Cytotoxic Drug Permeation testing click here
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EN374-2:2003 EN374-2:2003
Micro-organism protection
Standard EN374-2 requires glove manufacturers to select and
monitor against an Acceptable Quality Level (AQL) for pinhole
defects
Lower AQL = lower probability of pinhole defects
A pinhole carries the risk for a micro-organism to pass through
the glove
• Assess micro organism risk
• Define hazard classification of the biological agent
• Define size of micro-organism
• Select glove with appropriate Acceptable Quality Level (AQL)
- the lower the AQL, the higher the level of protection
o AQL 1.5 = Level 2 LEVEL 2/3
o AQL 0.65 = Level 3
Glove manufacturers are using the air and water tightness test as per EN374-2 which describes sampling and water tightness test method for
monitoring pinhole defects
For more detail on how to assess the nature and level of micro-organism risk click here
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EN374-3:2003 EN374-3:2003
Protection from Harsh Chemicals
(immersion protection)
This standard refers to applications involving risk of full
immersion of gloved hands in chemicals, such as industrial
chemical handling
The glove should achieve a breakthrough time of >30 minutes on
at least 3 of the following chemicals:
A: Methanol (100%) (CAS 67-56-1) B: Acetone (100%) (CAS 67-64-1)
C: Acetonitrile (100%) (CAS 75-05-8) D: Dichloromethane (100%) (CAS 75-09-2)
E: Carbon Disulphide (100%) (CAS 75-15-0) F: Toluene (100%) (CAS 108-88-3)
G: Diethylamine (100%) (CAS 109-89-7) H: Tetrahydrofurane (100%) (CAS 109-99-9)
I: Ethylacetate (100%) (CAS 141-78-6)
K: Sodium hydroxide (40%) (CAS 1310-73-2)
J: n-Heptane (100%) (CAS 142-85-5
L: Sulphuric Acid (96%). (CAS 7664-93-9)
A, K, L
Precision in the laboratory is best served by limiting chemical handling to low quantities with the widespread use of pipettes, thereby containing
chemical hazards to a splash type risk rather than a full immersion risk
Those gloves which do not meet the test standard can claim low chemical protection according to EN374-1:2003
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EN421:2010
Protection from Radioactive
particle Contamination
To protect from radioactive contamination, the glove has to be liquid
proof and needs to pass the penetration test defined in EN 374
• For use in containment enclosures the glove must also pass a
specific air pressure leak test
• Materials may be modelled by their behaviour to ozone cracking
This test is optional and can be used as an aid to selecting gloves
Protection from ionising radiation
To protect from ionising radiation, the glove has to contain
a certain amount of lead or equivalent metal, quoted as lead
equivalence. This lead equivalence is marked on each glove
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EN1149-5
Electrostatic properties
Antistatic claims can be made on PPE Category III disposable
gloves if they have been tested against either EN1149-1:2006
or EN1149-3:2004 and satisfy at least one
of the required levels:
• Surface Resistance (EN 1149-1:2006) must be
less than 5 x 1010 ohms
• Induction charging/Static Decay (EN 1149-3:2004)
Half decay time < 4 s or shielding factor > 0.2
This European Standard is not applicable for protection against
mains voltages and the requirements may not be sufficient in
oxygen enriched flammable atmospheres
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EN 388:2003
Mechanical Hazards
Protection against mechanical hazards is expressed by a
pictogram followed by four numbers (performance levels;
0-5), each representing test performance against a
specific hazard
No thin mil glove will pass these tests
n n n n
Abrasion resistance
Blade cut resistance
Tear resistance
Puncture resistance
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EN 407:2004
Thermal Hazards
The nature and degree of thermal protection is shown
by a pictogram followed by a series of six performance
levels (0-4), relating to specific protective qualities
Gloves must achieve at least performance level 1 for
abrasion and tear under EN 388:2003*
n n n n n n
Resistance to flammability
Contact heat resistance
Convective heat resistance
Radiant heat resistance
Resistance to small splashes of molten metal
Resistance to large quantities of molten meta
* the higher the number, the higher the protection level
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EN 511: 2006
Protection against cold
Protection against cold is expressed by a pictogram
followed by a series of 3 performance levels, relating
to specific protective qualities
Gloves must achieve at least performance level 1 for
abrasion and tear under EN 388:2003
n n n
Resistance to convective cold (performance level 0-4)*
Resistance to contact cold (performance level 0-4)*
Penetration by water (0 or 1)
0 = water penetration
1 = no water penetration
* the higher the number, the higher the protection level
APPENDIX
All KIMTECH SCIENCE* gloves are PPE Category III certified and
compliant with Medical Device standards EN455-1,-2,-3,-4
Protection level against risks
EN374- EN374- Virus
AQL Material Product
1:2003 1:2003 protection Glove Glove/
code Description Sizing
length Case
Biohazard Chemical Contaminants
0.65 ISO 16604: KIMTECH SCIENCE* PURPLE XS-
2004 Proc. B 97610-97614 NITRILE-XTRA* Gloves 30cm 500
XL
EN374-2: ISO 16604: XS- 1,000 (XL:
Virus
0.65 KIMTECH SCIENCE* PURPLE
2003 2004 Proc. B 90625-90629 NITRILE* Gloves XL 24-25cm 900)
ISO 16604: Nitrile KIMTECH SCIENCE* STERLING XS- 1,000 (XL:
0.65 2004 Proc. B 98341-98345 NITRILE-XTRA* Gloves XL
30cm 900)
EN374-1:
Bacteria
2003
ISO 16604: XS- 1,500
0.65 99210-99214 KIMTECH SCIENCE* STERLING
Level 3 2004 Proc. B
Gloves XL 24-25cm (XL: 1,400)
ISO 16604: KIMTECH SCIENCE* GREEN XS- 24-25cm 1,500
0.65 2004 Proc. B 99850-99854 (XL: 1,350)
NITRILE Gloves XL
EN374-2: 1.5 ISO 16604: 50501M KIMTECH SCIENCE* PFE-XTRA* XS- 28cm 500
2003 2004 Proc. B -50504M Gloves XL
Fungi
ISO 16604: Latex E110- XS- 1,000 (XL:
1.5 KIMTECH SCIENCE* PFE* Gloves
2004 Proc. B E550 XL 24-25cm 900)
1.5 ISO 16604: SP2110- KIMTECH SCIENCE* SATIN XS- 24-25cm 1,000 (XL:
Level 2 2004 Proc. B SP2550 PLUS* Gloves XL 900)
APPENDIX
How to assess micro-organism risk
For Viruses and Bacteria <500nm or Hazard Group Micro-Organism Sizes nanometers
3-4 biological agents, all criteria must be met: >2000 2000-1000 1000-500 500-300 300-100 100-50 50-10
Fungi
• AQL 0.65 / EN374-2:2003 level 3 Bacteria = High Risk of exposure
• Pass ISO 16604:2004 and ASTM F1671-97b Virus = Highest Risk
• Cuff Length 30cm with Double Donning
• Force at Break >7N Biological Agent Hazard Classification
• Consider a glove with higher thickness Category 2 Biological Agent Category 3-4 Biological Agents
1. The smaller the micro-organism, the greater Minimum Criteria for Glove Consideration
risk of penetration through a defect in the glove AQL 1.5 AQL 0.65
N/A ISO 16604/ ASTMF 1671
2. Consider Biological Agent’s Hazard Classification:
25cm length 30 cm length
Category 3-4 Biological Agents are highest risk to
human health Single Donning Double Donning
Force at Break >7 N Force at Break >7 N
Though not part of the EN374-2 test standard, ISO 16604:2004 and ASTM F1671-97b (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) are globally recognised test standard for the assessment of a glove resistance specifically to penetration by viruses. All
KIMTECH* gloves pass the ISO16604:2004 test
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Choosing the right glove
It is important to select gloves POWDER CONTAINS
with the appropriate level of CE FREE POWDER
certification but don’t forget to consider:
Powder free or not?
• Lower skin allergy risk - look for synthetic
materials such as nitrile instead of latex
LATEX
FREE LATEX
• Prevent skin irritation - look for Non
Detectable (ND) chemical accelerator levels
Non-latex or not?
• Reduce contamination risk - ask for trend
2
data around cleanliness
• Ensure correct size and fit
• Select features for performance - grip, length,
dexterity, comfort, insulation
Single use Recyclable
only
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KIMBERLY-CLARK PROFESSIONAL*
High quality PPE
is an expert supplier of high quality PPE
equipment with value added green,
lean and protection services
Knowledge
Contact: kimtech.support@kcc.com Engagement
Lean
solutions Training
Compliance
solutions
Health
& safety Glove &
garment
recycling
It all adds up...
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APPENDIX
Cytotoxic Drug Permeation testing
All KIMTECH SCIENCE* PURPLE NITRILE* and STERLING* Nitrile formulations
are tested according to ASTM D 6978-05 (Standard practice for assessment of
resistance of medical gloves to permeation by chemotherapy drugs)
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