Understanding glove certification

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1 Understanding glove certification It all adds up... to Exceptional Laboratories

2 Understanding glove certification Select a glove with the appropriate level of CE certification to address your application risk and performance requirements

3 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

4 EC type examination Category 1 Simple design Category 2 Intermediate design Category 3 Complex design Technical Documentation EC quality control system for the final product EC type-examination EC declaration of conformity nnnn

5 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

6 Personal protection PPE Category III gloves are a minimum requirement for personal protection in applications where there is exposure to chemicals or micro-organisms. It does not mean protection against all chemicals and micro-organisms. Assess the risk and refer glove performance data for EN374-1 and -2 test standards. Medical Device gloves are self-certified and are predominantly used for patient protection and other medical applications. This certification provides no standards for chemical protection. Category III Complex design 0120 Must pass EC type examination by notified body. For use in applications where effects are irreversible or mortal risk is present. Provides protection against microorganism and chemicals. For Personal protection in high risk applications Medical Device Directive Gloves EN455 Are SELF Certified. Not submitted for EC type examination. Object is care of the patient For Patient protection Medical Device Directive Gloves EN455 Are SELF Certified. Not submitted for EC type examination. Object is care of the patient For Patient protection Gloves classified as medical device only are not certified for Personal Protection.

7 EN Standards

8 EN420:2003 Describing general standards for protective gloves: Innocuousness Size Dexterity Package marking Instructions for use

EN374-1:2003 Low chemical protection (chemical splash protection only) EN374-1:2003 Gloves offering Low Chemical Protection are suitable for applications where chemical splash hazards are present.

9 EN374-1:2003 Low chemical protection (chemical splash protection only) EN374-1:2003 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

EN374-2:2003 Micro-organism protection EN374-2:2003 Standard EN374-2 requires glove manufacturers to select and monitor against an Acceptable Quality Level (AQL) for pinhole defects Lower AQL = lower

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 o AQL 0.

10 EN374-2:2003 Micro-organism protection EN374-2:2003 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 o AQL 0.65 = Level 3 LEVEL 2/3 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

EN374-3:2003 Protection from Harsh Chemicals (immersion protection) EN374-3:2003 This standard refers to applications involving risk of full immersion of gloved hands in chemicals, such as industrial

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:

11 EN374-3:2003 Protection from Harsh Chemicals (immersion protection) EN374-3:2003 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 ) B: Acetone (100%) (CAS ) C: Acetonitrile (100%) (CAS ) D: Dichloromethane (100%) (CAS ) E: Carbon Disulphide (100%) (CAS ) F: Toluene (100%) (CAS ) G: Diethylamine (100%) (CAS ) H: Tetrahydrofurane (100%) (CAS ) I: Ethylacetate (100%) (CAS ) J: n-heptane (100%) (CAS K: Sodium hydroxide (40%) (CAS ) L: Sulphuric Acid (96%). (CAS ) 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 Back to page 9

EN421:2010 Protection from Radioactive particle Contamination To protect from

the penetration test defined in EN 374 For use in containment enclosures the

modelled by their behaviour to ozone cracking This test is optional and can be

protect from ionising radiation, the glove has to contain a certain amount of

12 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

EN1149-5 Electrostatic properties Antistatic claims can be made on PPE Category III disposable gloves if they have been tested against

than 5 x 10 10 ohms Induction charging/static Decay (EN 1149-3:2004) Half decay time < 4 s or shielding factor > 0.

13 EN 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 :2006) must be less than 5 x ohms Induction charging/static Decay (EN :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

representing test performance against a specific hazard No thin mil glove will pass

14 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 Abrasion resistance Blade cut resistance Tear resistance Puncture resistance n n n n

388:2003* Resistance to flammability Contact heat resistance Convective heat resistance Radiant heat resistance Resistance to small

15 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* 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 n n n n n n * the higher the number, the higher the protection level

EN 388:2003 Resistance to convective cold (performance level 0-4)* Resistance to contact cold (performance level 0-4)*

16 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 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 n n n * 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 EN374-1:2003 EN374-1:2003 AQL Virus

B 97610-97614 KIMTECH SCIENCE* PURPLE NITRILE-XTRA* Gloves XS- XL 30cm 500 EN374-1: 2003 EN374-2: 2003 Level 3 EN374-2: 2003 0.65 0.65 0.65 0.65 1.5 1.5 ISO 16604: 2004 Proc. B ISO 16604: 2004 Proc.

B Nitrile Latex Virus Bacteria Fungi 90625-90629 98341-98345 99210-99214 99850-99854 50501M -50504M E110- E550 KIMTECH SCIENCE* PURPLE NITRILE* Gloves KIMTECH SCIENCE* STERLING NITRILE-XTRA* Gloves

17 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 EN374-1:2003 EN374-1:2003 AQL Virus protection Material Biohazard Chemical Contaminants Product code Description Sizing Glove length Glove/ Case 0.65 ISO 16604: 2004 Proc. B KIMTECH SCIENCE* PURPLE NITRILE-XTRA* Gloves XS- XL 30cm 500 EN374-1: 2003 EN374-2: 2003 Level 3 EN374-2: ISO 16604: 2004 Proc. B ISO 16604: 2004 Proc. B ISO 16604: 2004 Proc. B ISO 16604: 2004 Proc. B ISO 16604: 2004 Proc. B ISO 16604: 2004 Proc. B Nitrile Latex Virus Bacteria Fungi M M E110- E550 KIMTECH SCIENCE* PURPLE NITRILE* Gloves KIMTECH SCIENCE* STERLING NITRILE-XTRA* Gloves KIMTECH SCIENCE* STERLING Gloves KIMTECH SCIENCE* GREEN NITRILE Gloves KIMTECH SCIENCE* PFE-XTRA* Gloves KIMTECH SCIENCE* PFE* Gloves XS- XL XS- XL XS- XL XS- XL XS- XL XS- XL 24-25cm 30cm 24-25cm 24-25cm 28cm 24-25cm 1,000 (XL: 900) 1,000 (XL: 900) 1,500 (XL: 1,400) 1,500 (XL: 1,350) 500 1,000 (XL: 900) Level ISO 16604: 2004 Proc. B SP2110- SP2550 KIMTECH SCIENCE* SATIN PLUS* Gloves XS- XL 24-25cm 1,000 (XL: 900)

18 APPENDIX How to assess micro-organism risk For Viruses and Bacteria <500nm or Hazard Group 3-4 biological agents, all criteria must be met: AQL 0.65 / EN374-2:2003 level 3 Pass ISO 16604:2004 and ASTM F b Cuff Length 30cm with Double Donning Force at Break >7N Consider a glove with higher thickness 1. The smaller the micro-organism, the greater risk of penetration through a defect in the glove 2. Consider Biological Agent s Hazard Classification: Category 3-4 Biological Agents are highest risk to human health Micro-Organism Sizes nanometers > Fungi Bacteria = High Risk of exposure Virus = Highest Risk Biological Agent Hazard Classification Category 2 Biological Agent AQL 1.5 N/A 25cm length Category 3-4 Biological Agents Minimum Criteria for Glove Consideration Single Donning Force at Break >7 N AQL 0.65 ISO 16604/ ASTMF cm length Double Donning Force at Break >7 N Though not part of the EN374-2 test standard, ISO 16604:2004 and ASTM F b (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 Back to page 10

Choosing the right glove It is important to select gloves with the appropriate level of CE certification but don t forget to consider: POWDER FREE

Lower skin allergy risk - look for synthetic materials such as nitrile instead of latex Prevent skin irritation - look for Non Detectable (ND)

19 Choosing the right glove It is important to select gloves with the appropriate level of CE certification but don t forget to consider: POWDER FREE CONTAINS POWDER Powder free or not? Lower skin allergy risk - look for synthetic materials such as nitrile instead of latex Prevent skin irritation - look for Non Detectable (ND) chemical accelerator levels LATEX FREE LATEX Non-latex or not? Reduce contamination risk - ask for trend data around cleanliness 2 Ensure correct size and fit Select features for performance - grip, length, dexterity, comfort, insulation Single use only Recyclable

20 KIMBERLY-CLARK PROFESSIONAL* is an expert supplier of high quality PPE equipment with value added green, lean and protection services Contact: Knowledge High quality PPE Engagement Lean solutions Training Compliance solutions Health & safety It all adds up... to Exceptional Laboratories Glove & garment recycling

21 APPENDIX Cytotoxic Drug Permeation testing All KIMTECH SCIENCE* PURPLE NITRILE* and STERLING* Nitrile formulations are tested according to ASTM D (Standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs) Back to page 9

EN Standards Guide. Ansell summary guide to EN Standards that govern EU certified hand protection.

EN Standards Guide. Ansell summary guide to EN Standards that govern EU certified hand protection. EN Standards Guide Ansell summary guide to EN Standards that govern EU certified hand protection. Version 1.0 2016 CONTENTS 3 Contents 4 About the PPE Legislation 5 Working with Ansell 6 Provision of