Understanding EN 455‑3:2023 – biological evaluation
The 2023 revision makes chemical disclosure explicit. Endotoxin, powder and protein limits, the ISO 10993 link, and why "accelerator-free" now needs evidence.
A glove can be watertight and strong and still harm the person wearing it. EN 455-3 covers what the glove is made of and what it leaves on the skin: biocompatibility, residual chemicals, powder, protein and what the manufacturer must declare.
The 2023 revision supersedes EN 455-3:2015 and changes the nature of the obligation. It aligns with EN ISO 10993-1:2020, which treats biological evaluation as part of a risk-management process, and with the EU Medical Device Regulation (EU 2017/745). Chemical disclosure is now explicit rather than implied.
What changed in 2023
CEN approved EN 455-3:2023 on 29 October 2023. It took national status by May 2024, and conflicting national standards, including the 2015 edition, were withdrawn by November 2025. The standard itself lists six changes: updated terms and definitions; updated requirements, specifically chemicals, endotoxins and labelling; a clarification to 5.3 Note 2; an updated test report clause; Annex ZA realigned from the old Medical Devices Directive to the MDR; and a full editorial revision.
Two of those matter commercially. The Annex ZA realignment is what ties this part to Regulation (EU) 2017/745. The labelling changes are stricter than most buyers realise, and are covered below.
Manufacturers must identify and assess every biological risk arising from glove materials or from processing chemicals that remain as residues – and must provide a full list of chemical substances that are either intentionally added during manufacturing or known to remain in the finished product.
That list includes accelerators, antioxidants, biocides and stabilisers, the substances behind Type IV allergic reactions and, in some cases, reproductive toxicity. Wingstay L, a phenolic antioxidant on the EU REACH joint submission list of reproductive toxicants, is the example most often cited: it must be declared and assessed, and exposure must be shown to be eliminated or controlled below acceptable limits.
For buyers this is the useful shift. You can now ask for the chemical declaration and expect to receive one. A supplier who cannot produce it is not meeting the current standard.
Testing requirements
Endotoxin control matters most in neurosurgery and implant procedures, where a pyrogenic reaction carries serious clinical risk. Powdered gloves are discouraged outright – the respiratory and wound complications are well documented, and several countries including the USA and Japan have banned them for medical use. For latex gloves, Annexes B and C describe immunological and chromatographic methods for further protein and amino-acid analysis.
Biological testing itself is referenced out to the EN ISO 10993 series: -5 (cytotoxicity), -10 (irritation and sensitisation), and -17 and -18 (chemical characterisation and allowable limits).
Labelling and evidence
Labelling follows EN ISO 15223-1:2021, with several requirements that are worth knowing verbatim:
One material requirement also sits in this clause rather than in the test methods: gloves shall not be coated with talc (magnesium silicate).
Two evidence rules are worth quoting in a specification:
Both close the gap between a marketing claim and a demonstrated fact. Our biodegradable nitrile glove is formulated without accelerators for exactly this reason, and the supporting ISO 10993-10 results are part of its documentation.
How EN 455‑5:2025 extends it
EN 455-5, "Extractable Chemical Residues", is the analytical companion to EN 455-3. It standardises extraction under simulated-use conditions, chemical separation, and quantification of residues by HPLC or comparable validated methods – covering thiurams, carbamates, thiazoles and phenolic antioxidants.
Where EN 455-3 requires disclosure and assessment, EN 455-5 supplies the numbers. Used together they let a manufacturer substantiate a low-residual claim and satisfy both ISO 10993 and MDR expectations on chemical safety.
What to require in a tender
The EN 455 family
Key takeaways
Seventeen years sourcing and supplying medical gloves and PPE to governments, UN agencies, NGOs and healthcare systems. Writes on glove standards, quality management and responsible sourcing for institutional buyers, working from the source standards rather than secondary summaries.
View profile on LinkedIn
