European Standards

Medical and Protective gloves
CE marking is a part of the EU’s harmonization legislation. By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for the CE marking and can be sold throughout the European Economic Area (EEA).

In order to CE mark a glove, it needs to be suitable for either medical purpose or personal protection, which means that there are 2 different directives to comply with. Therefore the gloves must either comply with The Medical Device Directive (93/42/EEC) and/or The Personal Protective Equipment Directive (89/686/EEC).

To make sure that a glove complies with above standards, there are several Harmonized European Standards the gloves can be tested against. These standards will be explained below.

 

Harmonized European standards for Medical Gloves

EN 455-1 - Medical gloves for single use – Part 1:

Requirements and testing for freedom from holes.

This standard specifies the requirements and gives the test method in order to determine freedom from holes. The compliance level for freedom from holes shall be an AQL of 1,5.

 

EN 455-2 - Medical gloves for single use – Part 2:

Requirements and testing for physical properties.

This standard specifies the requirements and gives the test methods for physical properties in order to ensure that the gloves provide and maintain in use an adequate level of protection.

You will in this standard find the required dimensions of the gloves for the different sizes, as well as the requirements for the Force at Break:

	Surgical gloves	Examination/procedure gloves
	All types	All types except gloves from thermoplastic	Thermoplastic material (e.g. Polyvinyl chloride)
Force at break throughout shelf life	> 9,0 Newton	> 6,0 Newton	> 3,6 Newton

 

EN 455-3: Medical gloves for single use – Part 3:

Requirements and testing for biological evaluation.

This standard specifies the requirements for the evaluation of biological safety. It gives requirements for labelling and the disclosure of information relevant to the test methods used. It includes: Endotoxins for sterile gloves, latex proteins for gloves from natural rubber latex, chemical residues and powder.

 

EN 455-4: Medical gloves for single use – Part 4:

Requirements and testing for shelf life determination.

This standard specifies the requirements for shelf life as well as requirements for labelling. Maximum shelf life is 3 years when using the accelerated shelf life determination and 5 years with real time shelf life determination.

 

Harmonized European standards for Protective Gloves

Protective gloves are divided into 3 categories:

• Category 1 – Simple category (for minimal risk only)
• Category 2 – Intermediate category
• Category 3 – Complex category

Harmonized European standards for Protective gloves. Below only the standards that are relevant for gloves sold by Abena are explained.

 

EN 420: Protective gloves – General requirements and testing methods:

It defines general requirements for protective gloves.

 

EN 374-1: Protective gloves against chemicals and micro-organisms – Part 1:

Terminology and performance requirements.

The standard specifies the requirements for gloves to protect the user against chemicals and/or micro-organisms and defines terms to be used.

 

EN 374-2: Protective gloves against dangerous chemicals and micro-organisms – Part 2:

Determination of resistance to penetration.

Specifies a test method for the penetration resistance of gloves that protect against dangerous chemicals and/or micro-organisms.

If the glove meets Level 2 for penetration, which is AQL 1,5, you can attach following symbol:

 

Penetration: movement of a chemical or micro-organism on a non-molecular level

EN 374-3: Protective gloves against chemicals and micro-organisms – Part 3:

Determination of resistance to permeation by chemicals.

This standard has been superseded by EN 16523-1. You will still find results where the test method from EN 374-3 has been used.

It specifies a test method for the determination of the resistance of protective gloves to permeation of potential hazardous liquid chemicals und continuous contact.

If 3 chemicals in below table reaches a permeation level of no less than 2, the glove can be marked with the symbol for chemical hazard and should be accompanied by the letters referring to those chemicals.

 

Permeation: movement of a chemical on a molecular level.

 

Code letter	Chemical	CAS Number	Class
A	Methanol	67-56-1	Primary alcohol
B	Acetone	67-64-1	Ketone
C	Acetonitrile	75-05-8	Nitrile compound
D	Dichloromethane	75-09-2	Chlorinated paraffin
E	Carbon disulphide	75-15-0	Sulphur containing organic compound
F	Toluene	108-88-3	Aromatic hydrocarbon
G	Diethylamine	109-89-7	Amine
H	Tetrahydrofurane	109-99-9	Heterocyclic and ether compound
I	Ethyl acetate	141-78-6	Ester
J	n-Heptane	142-85-5	Saturated hydrocarbon
K	Sodium hydroxide 40%	1310-73-2	Inorganic base
L	Sulphuric acid 96%	7664-93-9	Inorganic mineral acid

 

Measured breakthrough time (min)	Permeation performance level
>10	1
>30	2
>60	3
>120	4
>240	5
>480	6

 

 

EN 388: Protective gloves against mechanical risks.

Specifies a requirements, test methods, marking and information to be supplied for protective gloves against the hazards tested in this standard.

The below pictogram is used when the glove is tested against mechanical risks it is follow by 4 digits that in below given order shows how resistant the glove is against the specified mechanical risks.

Test	Level of performance
Abrasion resistance	1-4
Blade cut resistance	1-5
Tear resistance	1-4
Puncture resistance	1-4

Level 1 is the lowest performance level