Understanding the legislation for the labelling and classification of gloves can be difficult. Get a short overview of the relevant directives, regulations and standards for gloves sold by Abena.
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-labelled 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.
Medical gloves must comply with the medical device directive (MDD93/42/EEC). In May 2020 this was changed to regulation MDR (EU) 2017/745 instead of a directive.
To show compliance the gloves are currently tested according to several harmonized 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 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 420:2003+1:2009 Protective gloves – General requirements and testing methods
EN ISO 21420:2020 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
EN 374-4:2019 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.