EN 455 sets the requirements for single-use medical gloves. It is important to understand that medical and protective gloves fall under different regulations: a medical glove is governed by the Medical Devices Regulation (MDR 2017/745), a protective glove by the PPE Regulation (2016/425).
The four parts
- EN 455-1
- Freedom from holes — the water leak test, AQL ≤1.5
- EN 455-2
- Physical properties — dimensions, force at break and elongation
- EN 455-3
- Biological evaluation — protein, endotoxin and powder content
- EN 455-4
- Determination of shelf life
Dual certification
In many settings — laboratories, pathology, ambulance work — a glove must protect the patient and the wearer at once. That calls for a dual-certified glove: EN 455 (medical device) plus EN ISO 374-1 and EN ISO 374-5 (chemical and biological PPE). Both markings must appear on the same box.
Powder and latex
Powdered gloves have effectively been withdrawn in the EU: the powder carries latex protein into the air and causes allergic sensitisation. Alternatives to natural latex are nitrile (the best mechanical and chemical resistance), vinyl (economical, for low-risk tasks) and neoprene.