Regulation and Standards

REGULATIONS AND STANDARDS RELATING
TO LABORATORY GLOVES AND CLEANROOM GLOVES

Complex Design covers the highest level of risk, otherwise defined as irreversible and mortal risk. Disposable gloves in this
category are typically those gloves that provide protection against chemical and microorganisms. For these gloves the following
normative references may apply: ISO 21420:2020+A1:2022 (general requirements for gloves), ISO 374-1:2016+A1:2018 (terminology and
performance requirements for chemical risks) and ISO 374-5:2016 (terminology and performance requirements for
micro-organisms risks).

Crucially complex design brings the need for regular auditing by an external organization body, called a Notified Body.  The
presence of the Notified Body is clearly evident, as under the CE mark will appear four digits (e.g. 0598 = SGS, 0493=Centexbel,
0123=TÜV etc). The Notified Body validates the quality assurance system used by the manufacturer.

In addition, disposable gloves that have been registered as Complex Design will typically display two or three pictograms identifying
the relevant standards to which they have been tested.

REFERENCE	SCOPE	PICTOGRAM
Regulation (EU) 2016/425	General requirements for the design and manufacture of Personal Protective Equipment (PPE).   User Information	PPE Cat. I & II PPE Cat.III
Regulation (EU) 2017/745	Medical devices Regulation.
ISO 21420:2020+A1:2022	Protective gloves – General requirements and test methods for glove design, construction, resistance of glove materials to water penetration, innocuousness, comfort and efficiency, marking and information supplied by the manufacturer applicable to all protective gloves.	N/A

 

CHEMICAL RISK

REFERENCE	SCOPE
ISO 374-1:2016+A1:2018	Protective gloves against dangerous chemicals and micro-organisms – Part 1: Terminology and performance requirements for chemical risks.
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.
ISO 374-2:2019	Protective gloves against dangerous chemicals and micro-organisms – Part 2: Determination of resistance to penetration.
ISO 374-4:2019	Protective gloves against dangerous chemicals and micro-organisms – Part 4: Determination of resistance to degradation by chemicals.

 

Gloves are classified as Type A, B or C depending on their performance level when tested against a number of chemicals and degradation
expressed in terms of mean average (% change in puncture resistance before and after chemical exposure).

 

 

BIOLOGICAL RISK

REFERENCE	SCOPE
ISO 374-5:2016	Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risks.
ISO 374-2:2019	Protective gloves against dangerous chemicals and micro-organisms – Part 2: Determination of resistance to penetration.
ISO 16604:2004 Procedure B	Clothing for protection against contact with blood and body fluids – Determination of resistance of protective clothing materials to penetration by blood-borne pathogens – Test method using Phi-X174 bacteriophage.

 

ISO 374-2 :2019 remains the basic test for assessing resistance to penetration by micro-organisms. Here performance is measured
on the basis of AQL (AQL<4 or Level 1 to AQL <0.65 or Level 3, with Level 3 being the highest performance level). For protective
gloves against bacteria and fungi, the biohazard pictogram is applied.

For protection against bacteria, fungi, and virus, the biohazard pictogram is accompanied with the term “VIRUS “underneath.
To fulfil this requirement, the glove must be tested according to ISO 374-2:2019 for bacteria and fungi and also tested according
to ISO 16604: 2004 (Method B) using the bacteriophage penetration test.

 

MICRO-ORGANISMS RESISTANT	VIRUS RESISTANT
Level 1	AQL<4
Level 2	AQL<1.5
Level 3	AQL<0.65

 

MECHANICAL RISK

REFERENCE	SCOPE	PICTOGRAM
EN 388:2016+A1:2018	Protective gloves against mechanical risks. This standard covers mechanical risks such as abrasion, blade cut, tear, puncture and if applicable impact. A pictogram identifying a glove offering protection against mechanical risks will have underneath up to four numbers and where appropriate up to two letters. These signs indicate the performance of the glove.

 

RADIOACTIVE CONTAMINATION RISK

REFERENCE	SCOPE
EN 421:2010	Protective gloves against ionizing radiation and radioactive contamination.

 

MEDICAL USE

REFERENCE	SCOPE
EN 455-1:2020	Medical gloves for single use – Part1: Requirement and testing for freedom from holes.
EN 455-2:2015	Medical gloves for single use – Part 2: Requirement and testing for physical properties.
EN 455-3:2015	Medical gloves for single use – Part 3:  Requirement and testing for biological evaluation.
EN 455-4:2009	Medical gloves for single use – Part 4:   Requirement and testing for shelf-life determination.

 

OTHER REGULATIONS AND STANDARDS

REFERENCE	SCOPE
ANSI/AAMI/EN ISO 1137-2:2015	Gamma Sterilization Dose Auditing
ASTM D257-07	Standard Test Methods for DC Resistance or Conductance of Insulating Materials
ASTM D257-36	Standard Test Methods for DC Resistance or Conductance of Insulating Materials
ASTM D3578-05	Standard Specification for Rubber Examination Gloves
ASTM D3767-03 (2020)	Standard Practice for Rubber—Measurement of Dimensions
ASTM D412-06ae2	Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D412-06ae2	Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D5712-15 (2020)	Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method
ASTM D6124-06	Standard Test Method for Residual Powder on Medical Gloves
ASTM D6319-10	Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D6978-05 (2019)	Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
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
ASTM F720-81	Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
ASTM D573-04 (2019)	Standard Test Method for Rubber—Deterioration in an Air Oven
Directive 72/2002/EC	relating to plastic materials and articles intended to come into contact with foodstuffs
EC 1935/2004	Directive on materials and articles intended to come into contact with food
EN 1149-1/2/3 & 5	Protective clothing – Electrostatic properties
FDA 21CFR177.2600	FDA – Food for Human Consumption – Indirect Food Additives: Polymers – Rubber article intended for repeated use
IEST-RP-C005.4 (2013)	Gloves and Finger Cots Used in Cleanrooms and Other Controlled Environments
ISO 13485:2016	Medical devices – Quality management systems — Requirements for regulatory purposes
ISO 21171:2006	Medical gloves – Determination of removable surface powder
ISO 9001:2015	Quality management systems — Requirements
ISO 14001:2015	Environmental management systems

 

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