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 marked with the CE-label. Gloves can be CE-labeled as a medical device, as a personal protective equipment, or as both. In order to be labeled 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 micro-organisms – Part 1: Terminology and performance requirements.
- EN 374-2:2016 Protective gloves against dangerous chemicals and micro-organisms – 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 micro-organisms. Determination of resistance to degradation by chemicals
- EN374-5:2016 Protective gloves against dangerous chemicals and micro-organisms. Terminology and performance requirements for micro-organisms risks
- EN 388:2016 Protective gloves against mechanical risks.