CE mark
The CE mark indicates that a product may be legally offered for sale in any country within the European Union. The sale of gloves in the EU requires that the product is labelled with the CE mark. Gloves can be CE marked as a medical device, as a personal protective equipment, or as both. In order to be labelled as both, the gloves must comply with the legislation as described below.
What is the difference between a medical glove and a protective glove?
- A medical device is defined as: a glove intended for use in the medical field to protect the patient and user from cross-contamination.
- A protective glove is defined as: personal protective equipment, which protects the hand or part of the hand against hazards. In addition it can cover part of the arm and forearm
Legislation | Standards
Medical Gloves:
Medical gloves must comply with the medical device directive (MDD93/42/EEC). Starting May 2020, this will be changed to regulation MDR (EU) 2017/745 instead of a directive.
To show compliance the gloves are currently tested according to several harmonised standards:
- EN 455-1 - Medical gloves for single use – Part 1: Requirements and testing for freedom from holes
- EN 455-2 - Medical gloves for single use – Part 2: Requirements and testing for physical properties.
- EN 455-3: Medical gloves for single use – Part 3: Requirements and testing for biological evaluation.
- EN 455-4: Medical gloves for single use – Part 4: Requirements and testing for shelf life determination.
Protective Gloves:
Protective gloves must comply with the requirements of the directive for the Personal Protective Equipment (89/686/EEC). Products produced after April 2019, will need to comply to PPE Regulation (EU) 2016/425. The standards which apply to protective gloves include:
- EN 420: Protective gloves – General requirements and testing methods
- EN 374-1:2016 Protective gloves against chemicals and microorganisms – Part 1: Terminology and performance requirements.
- EN 374-2:2016 Protective gloves against dangerous chemicals and microorganisms – Part 2: Determination of resistance to penetration.
- EN 16523-1:2015 Determination of material resistance to permeation by chemicals - part 1: Permeation by liquid chemical under condition of continuous contact
- EN374-4:2013 Protective gloves against chemicals and microorganisms. Determination of resistance to degradation by chemicals
- EN374-5:2016 Protective gloves against dangerous chemicals and microorganisms. Terminology and performance requirements for microorganisms risks
- EN 388:2016 Protective gloves against mechanical risks.