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.
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:
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:
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:
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.
Protective gloves are divided into 3 categories:
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:
EN 374-1: Protective gloves against chemicals and micro-organisms – Part 1:
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:
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:
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