CE marking may seem complex to understand. Our experts are there to provide you with clear explanations and practical advice to help you gain a better understanding of personal protective equipment (PPE) regulations and usage, in particular for PPE gloves.

 

For PPE glove users

The obligations are set out in the “PPE users” directive, namely Directive 89/656/EEC of 1989-11-30 and related legislation (2009/104/EC and 2019/1832).

Employers are required to put in place comprehensive measures to protect their employees. PPE provides protection against residual risks. The employer must ensure that the PPE is appropriate to the risks, in collaboration with the company’s various internal committees.

PPE that offers the appropriate level of protection must be made available to employees free of charge. It must include:

• CE marking to certify conformity;
• complete user information on each pair of gloves;
• manufacturer’s declaration of conformity.

 

What does a CE-type examination involve?

 

PPE manufacturers and European Regulation (EU) 2016/425

The products that PPE glove manufacturers place on the market must comply with the essential requirements of European Regulation (EU) 2016/425.

To this end, the manufacturers must abide by the following procedure:

1. Characterise the level of risk against which their PPE glove is going to protect its user. This will define the certification rules (see A).
    
2. Precisely define all the risks. This will set all the necessary standards during the certification process (see B).
    
3. The manufacturer will choose its notified body, namely CTC.
   The majority of PPE gloves (see C) are Category II. For Category III PPE gloves, an annual control system should be established (Module C2 with CTC or Module D with another notified body).
    
4. The manufacturer will send the notified body a product specification sheet, which includes:
   • the risks covered by the PPE as well as its field of use
   • a complete description of production (materials, assembly site, etc.);
   • the results of tests confirming the conformity of the products (see B);
   • the final marking of the PPE glove (see D);
   • the PPE instruction manual.
      
5. Once the notified body has awarded an EU-type certification number, the manufacturer:
   • issues its declaration of conformity;
   • affixes the CE marking on its products;
   • may sell its PPE gloves throughout the European Union and in many other countries;
   • remains at the disposal of the market surveillance authorities;
   • undertakes an annual production control (Module C) to ensure that all production is homogenous, complies with the requirements of the regulation and achieves the performance levels set on the EU-type examination certificate.

 

A. Characterise the level of risk

Certification rules for PPE - Protective gloves

Certification rules	Category I	Category II	Category III
	Minor risks	Other risks	Fatal or irreversible risks
Procedures	Module A	Module B and Module C	Module B, Module C and Module C2 or D
Examples	Gardening glove against surface abrasion	Mechanical risks glove	Chemical risks glove
Manufacturer's obligations
	Technical file Instructions for use Technical file	Technical file Instructions for use Technical file	Technical file Instructions for use Technical file
	N/A	CE examination by a NB	CE examination by a NB
	Monitoring of conformity of production by the manufacturer	Monitoring of conformity of production by the manufacturer	Monitoring of conformity of production by the manufacturer Annual production control by NB
	Declaration of conformity CE marking	Declaration of conformity CE marking	Declaration of conformity CE marking

 

B. Choose the PPE protective gloves standard(s)

EN ISO 21420	Protective gloves - General requirements
EN 388	Protective gloves against mechanical risks
EN 407	Protective gloves against thermal risks (heat and/or fire)
EN 421	Protective gloves against ionising radiation and radioactive contamination
EN 511	Protective gloves against cold
EN 659	Protective gloves for firefighters
EN 1082-1	Gloves and arm guards against cuts and stabs by hand knives - Part 1: chain mail gloves and arm guards
EN 1082-2	Gloves and arm guards protecting against cuts and stabs by hand knives - Part 2: gloves and arm guards made of materials other than chain mail
EN 1082-3	Gloves and armguards protecting against cuts and stabs by hand knives - Part 3: impact cut test for fabric, leather and other materials
EN 12477	Protective gloves for welders
EN 13594	Protective gloves for motorcyclists
EN 14328	Gloves and arm guards against cuts by electric knives - Requirements and test methods
EN 16027	Protective gloves for association football goalkeepers
EN 16350	Protective gloves - Electrostatic properties
EN ISO 374-1	Protective gloves against hazardous chemicals and micro-organisms - Part 1: Terminology and performance requirements for chemical hazards
EN ISO 374-5	Protective gloves against hazardous chemicals and micro-organisms - Part 5: Terminology and performance requirements for risks related to micro-organisms and viruses
EN ISO 10819	Hand-arm vibration - Measurement and evaluation of the vibration transmission factor of gloves to the palm of the hand
EN ISO 11393-4	Protective clothing for users of hand-held chainsaws - Part 4: Test methods and performance requirements for protective gloves
ISO 18889	Protective gloves for pesticide applicators and re-entry workers
ANSI/ISEA 105	Classification for hand and arm protection (standard for the US market)

 

C. Choose your notified body (NB)

In 1992, CTC became one of the very first PPE notified bodies (NB), assigned number 0075. Since this date, we have issued more than 45,000 EU type-examination certificates for safety footwear, protective gloves and protective clothing.  

Our competencies are assessed and guaranteed by our ISO 17025 (Testing) and ISO 17065 (Certification) accreditations. 

The professionalism and validity of our physical and technical tests help our clients make the safest PPE gloves.

CTC has extensive and long-standing experience in the safety testing of materials and products. The European REACh legislation is the strictest in the world. CTC will help you determine which relevant critical substances to test for. Incorporating safety requirements helps to ensure that the products comply with Annex XVII of the REACh Regulation. 

CTC participates actively in PPE standardisation as well as in the coordination of notified bodies (NB).

 [ST1]Dans le texte français vous parlez de chaussures ici alors que vous voulez dire gants, en tout cas j’ai corrigé dans la version anglaise

	CTC Shanghai and CTC Dongguan CNAS-accredited laboratories CTC Shanghai: CNAS L4577 CTC Dongguan: CNAS L5912
CTC Asia, HKAS-accredited laboratories in Hong Kong

 

D. Marking system for protective gloves

All CE-marked gloves guarantee a high level of protection, comfort and durability based on the following marking standards: 

The gloves must conform to the requirements of the European regulation. Conformity is established by the implementation of harmonised European standards applicable in all European Union countries. 

• Use of CE marking: manufacturers accept their responsibility with regard to the conformity of their products. This conformity is verified by a notified body designated by its national authorities and registered with the European Commission (NANDO database). 
• In addition to the CE marking, international standards impose a secondary indication identifying the protection claimed by the gloves.

MECHANICAL RISKS EN 388 - WXYZα (P)	COLD RISKS EN 511 - XYZ	CHEMICAL HAZARDS EN ISO 374-1
IMPACT CUT  EN 1082	RISKS RELATED TO MICRO-ORGANISMS AND VIRUSES EN ISO 374-5	THERMAL RISKS EN 407 - EN 12477
		or
RADIOACTIVE CONTAMINATION EN 421	HEAT AND FIRE HAZARDS FOR FIREFIGHTERS EN 659	HAND-HELD CHAIN SAWS EN ISO 11393-4
MOTORCYCLISTS EN 13594	RISKS ASSOCIATED WITH PESTICIDES ISO 18889	INFORMATION

 

Safety glove design