EN 455-3
EN 455-3 is part of the EN 455 series and sets requirements for the biological safety of medical single-use gloves.
Test parameters:
1. Cytotoxicity (per ISO 10993-5): glove extracts must not cause significant cell damage on contact with cell cultures (typically Grade 0 or 1)
2. Water-soluble substances (residual chemicals, extractables): limits for chemical residues from the manufacturing process
3. Protein content (latex gloves only): limits on latex protein to reduce Type I allergy risk
Different limits apply to powder-free versus powdered gloves. For gloves declared powder-free, EN 455-3 limits powder residue to a maximum of 2 mg per glove.
EN 455-3 does not require a full biological evaluation per ISO 10993 for all endpoints, but tests the parameters relevant to the specific use case (short-term contact with skin and mucous membranes).
A failed EN 455-3 result (e.g. cytotoxicity Grade 3+) means the glove does not meet requirements and may not be placed on the market as a medical device.
Frequently asked questions
What additional test applies to latex gloves under EN 455-3?
Latex gloves are additionally tested for protein content to limit allergen potential (Type I latex allergy). Latex proteins can trigger IgE-mediated immediate hypersensitivity reactions.