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Hand protection equipment: European standards

 

All personal protective equipment (PPE) is subject to European regulations. Protecfina standards

 

PPE must satisfy essential requirements imposed by European directives and defined by standards (EN). While the CE marking allows products to circulate freely throughout the EU, there must be a technical file, a declaration of conformity and a user manual drafted in the language of the country in which they are used.

Of all the disposable or single-use hygiene PPE (caps, masks, aprons, etc.) only gloves must comply with standards, the other equipment is considered just as work clothing.

 

On the production lines, the use of advanced technologies and stringent testing at each step of the production of PROTECFINA gloves guarantees reliability and safety.  Beyond the applicable standards, PROTECFINA strives towards optimal quality in order to best satisfy the requirements of its customers.

 

travailler-mieux.gouv.fr/
Gants-risques

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THE FRENCH LABOUR DEPARTMENT’S WEBSITE PROVIDES A WIDE RANGE OF INFORMATION CONCERNING RISKS AND PPE

Independent notified bodies

 SGS Groupe France

T.Ü.V Rheinland

THE TWO FOLLOWING BODIES HAVE TESTED
AND CERTIFIED OUR GLOVES
(PPE AND MEDICAL)

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Thanks to our glove performance levels, our gloves also comply with certain medical standards and therefore have dual certification.

 

Although the materials used are not within the field of action of directives 67/548/EEC and 1999/45/CE, each glove has its own Material Security Data Sheet (MSDS). This data sheet is available on request.

Standards and directives governing gloves and PPE :

DIRECTIVE 89/686/EEC

 

REGULATION  1935/2004/EEC

 

EN 420

 

EN 374- 1

 

 

EN 374-2

 

 

EN 374-3

Relating to personal protective equipment and CE marking nitrile/protile weighed glove

 

Relating to materials and articles intended to come into contact with food

 

Protective gloves – General requirements and test methods

 

Protective gloves against dangerous chemicals and micro-organisms

Part 1 – Terminology and performance requirements

 

Protective gloves against dangerous chemicals and micro-organisms

Part 2 -Determination of resistance to penetration

 

Protective gloves against dangerous chemicals and micro-organisms

Part 3 -Determination of resistance to permeation by chemicals

 

In addition, DIRECTIVE 89/656/EEC concerns the minimum health and safety requirements for the use of personal protective equipment: employer obligations, choice of equipment, general rules for use and user information.

OUR GLOVE MANUFACTURING PROCESS INCLUDES A MILD CHLORINATION OPERATION (ROUGH EFFECT) TO REMOVE DUST, THUS PROVIDING :

A stronger and more regular grip for optimal tactile grasp, especially for small items and objects with smooth surfaces

 

A longer lifespan thanks to this technology which ensures minimal damage to the surface of the glove

 

Better conservation of the environment

 

A more consistent overall glove colour

 

Concerning EN 374-2 (Resistance to penetration by air and water)

This standard describes the test conditions for resistance of the gloves to penetration by air and water. It specifies that 4 samples of gloves must be tested for each size, i.e. a total of 20 gloves. The glove surface that forms a band of 4 cm from the edge of the cuff is not subject to testing. The test begins with a visual inspection of the entire surface of the glove. If the 3 tests (visual, air, water) are satisfactory, the glove is declared compliant.

Screwdriver resistance 017.

 

EN 374 -2 considers that a glove conforming to this test (EN 374-2) is an effective barrier against microbiological risks (microorganisms), except viruses. Furthermore, protection against microbiological risks may be claimed if the AQL (Acceptable Quality Level) is less than 1.5 (G1 control level of ISO 2859).

 

This AQL is tested by the manufacturer's quality service, which leaves some latitude to the manufacturer.

The number of samples to be tested and the tolerable number of defective gloves are defined in IS0 2859 tables.  An AQL of 1.5 means that at the end of production, out of a batch of 10,000 gloves produced, a sample of 200 gloves is taken for testing and for this sample of 200 gloves, the tolerance is a maximum of 7 defective gloves.

 

A micro-organism or microbe is a living organism which can only be seen through a microscope.

Micro-organisms are represented by various forms of life including bacteria and archaebacteria, certain fungi and also protists. Microscopic plants such as green algae and animals such as marine plankton, planar or amoebae are also micro-organisms.

Test principle for single-use gloves

A glove is immersed in water then inflated with air pressure in proportion to the thickness of the glove as defined in EN 374-2 page 5.

The pressure must be reached within 2 minutes and the length of the test (presence or absence of bubbles) must not exceed 30 seconds. If no bubbles appear, the glove is compliant.

The glove is filled with water (approximately 1 litre at room temperature) then immediately checked for leaks.

If no leak is detected, a second inspection is carried out 2 minutes later.

If droplets appear on the glove surface, the glove is not compliant.

 

 

AIR LEAK

 WATER LEAK

Performance levels are based on laboratory test results which do not always reflect actual conditions of use. In the workplace, various other factors such as temperature, abrasion, degradation, the products handled, influence the behaviour of the glove. Nothing replaces field testing in real conditions to determine glove strength and suitability for the intended tasks.

Observation

PROTECFINA IS AT YOUR SERVICE TO ADVISE YOU CONCERNING YOUR ACTIVITY.

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Protecfina

PROTECFINA is a French company that specialises in the manufacture of single-use individual protective gloves.

PROTECFINA is a sister company of THERMOFINA, created in 2012 to respond to requests from non-medical professionals.

Address :
230 avenue André Ampère
77194 Dammarie-lès-Lys Cedex - France

Tel. : 33 (0)1 64 37 00 87

 

Opening hours:

8:30 a.m. to 5:30 p.m. without interruption

5 days/7 – all year round

 

 

 MEDICAL DEVICES SOLUTION

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