Accredited testing of disposable gloves in accordance with the European standards EN 455 or EN 374 for personal protective equipment for manufacturers, importers, and distributors.

Medical grade disposable gloves are also known as latex gloves, nitrile gloves, exam gloves, protective gloves or surgical gloves and are used as protection against infection and similar harmful exposure to chemicals and microorganisms. 

Is CE marking a requirement for disposable gloves?

Yes, disposable gloves are considered a personal protective equipment. If you want to market and sell disposable gloves in the EU, including the Danish market, they must be CE marked. 

We offer accredited testing of disposable gloves in accordance with the European standard EN 455 or EN 374 for personal protective equipment, thereby allowing you the possibility of obtaining the CE marking of your product. 

With a CE mark, you can document to customers and authorities that your product meets the requirements for quality, safety, and performance in accordance with applicable standards. 

What are the requirements for disposable gloves?

The standard EN 455 covers all types of disposable gloves, both sterile and non-sterile, and in all types of material, including vinyl, latex, and nitrile. The standard specifies requirements for:

  • Liquid tightness
  • Physical properties
  • Biocompatibility
  • Shelf-life

The standard EN 374 covers protective gloves against dangerous chemicals and microorganisms. The standard specifies requirements for: 

  • Performance
  • Resistance to permeation
  • Resistance to permeation by chemicals

In addition, requirements are set for specifications regarding dimensions, touch, flexibility, marking, storage, etc. 

How to get your disposable gloves CE marked

As a distributor of disposable gloves, you are responsible for ensuring that your products meet the requirements of the standard and that your products are CE marked. 

For disposable gloves approved as personal protective equipment (PPE), a notified body, such as FORCE Certification (LINK), must issue a CE mark to your product based on the documentation available from testing the product.

Accredited test laboratory for personal protective equipment

FORCE Technology is accredited by DANAK (65 and 8) for testing personal protective equipment. Accredited testing may form the basis of an EC type examination (CE marking) of the product by a Notified Body, such as FORCE Certification. 

Services related to COVID-19

Test and approval of Personal Protective Equipment and medical devices