Understanding EN 455‑1:2020+A2:2024 – freedom from holes
Part one of the medical glove standard sets one requirement – no leakage – and the AQL that decides whether a batch passes. Which edition is in force, and what to ask for in a tender.
A glove with a hole in it is not protection – it is a false sense of it. EN 455-1 is the part of the European medical glove standard that deals with exactly this: whether a single-use medical glove leaks. It is the first of five parts, and the one most often quoted in tender documents, because it is the easiest requirement to verify and the hardest to fake.
This article is part of our series on the medical glove standard, which begins with an introduction to EN 455.
What the standard requires
One requirement, stated plainly: a single-use medical glove must not leak when tested with the water tightness test.
There is no acceptable level of leakage for an individual glove. What is defined instead is how many gloves in a sampled batch may fail before the batch itself is rejected – the Acceptable Quality Limit.
An AQL of 1.5 does not mean 1.5 % of delivered gloves leak. It means the batch was sampled and inspected to a statistical plan that rejects lots whose defect rate exceeds that limit. Sampling uses standardised AQL procedures at general inspection level I, with a minimum sample size and accept/reject numbers equivalent to sample size code letter L.
What the current edition is
The edition in force is EN 455-1:2020+A2:2024. The base standard was approved by CEN on 16 December 2021 and Amendment 2 on 12 August 2024, published as DS/EN 455-1:2020+A2:2024 in September 2024. It supersedes DS/EN 455-1:2020+A1:2022. Two older citations remain in wide circulation and both are wrong: plain "EN 455-1:2020", and "EN 455-1:2020+A1:2022".
The 2020 edition itself introduced four changes against the 2000 version: a note to entry on the definition of a single-use medical glove, a new definition of "hole", an enhanced referee test covering what happens when a glove extends under the weight of the water, and a new Annex A.
The harmonisation status contradicts the standard's own text
This one catches people out, including suppliers acting in good faith, so it is worth stating precisely.
EN 455-1:2020+A2:2024 is a harmonised standard under the MDR. It was added to the list by Commission Implementing Decision (EU) 2025/681 of 8 April 2025, which amended Decision (EU) 2021/1182. Compliance therefore carries presumption of conformity with the corresponding General Safety and Performance Requirements of Regulation (EU) 2017/745.
But if you open the standard, its own European foreword says the opposite. Point (e) states that because there is currently no standardisation request from the Commission for this part of EN 455, the harmonisation process to provide presumption of conformity to the MDR cannot be applied, and that Annex A is offered merely as guidance on the relationship to Regulation (EU) 2017/745.
Both statements were true when written. The A2 text was finalised in August 2024; the harmonisation decision came eight months later, in April 2025. The standard was not reissued to reflect it. So a quality manager reading the document in front of them will reach the wrong conclusion about its legal effect, and a supplier quoting the foreword back at you is quoting accurately from an out-of-date passage.
The practical point: presumption of conformity attaches to EN 455-1:2020+A2:2024 specifically. A supplier holding test reports against the 2020 or A1:2022 text is outside it, even where the test performed was identical.
The water tightness test
The glove is attached to a filling tube, overlapping the cuff by no more than 40 mm, and (1 000 ± 50) ml of water at 15 °C to 35 °C is poured in and allowed to distribute into every finger. The glove is inspected immediately, then again after 2 to 3 minutes.
One detail is routinely missed in supplier discussions: leakage within 40 mm of the cuff does not count. That zone is where the glove is clamped, so a leak there is an artefact of the test rather than a defect. If the glove stretches so far that 1 000 ml no longer fills it, the laboratory must still ensure every part is tested, for example by clamping sequentially.
The standard distinguishes two contexts:
A test report must contain, at minimum: a reference to EN 455-1; the glove type and manufacturing batch code; the name and address of the manufacturer or distributor and of the test laboratory if different; the date of the test; and the results, stated as batch size, sample size and number of non-conforming gloves.
Those last three numbers are the ones to look for. A report that gives a pass without the batch size, sample size and non-conforming count has not told you what was actually tested. And a compliance statement with no report behind it is not evidence of compliance at all.
What to require in a tender
If you are writing a specification, four lines cover it:
Asking for the report rather than the claim is the single most effective filter in glove procurement. Our own examination gloves are managed to AQL 1.5 with pre-shipment inspection by SGS or TÜV, and the reports travel with the product.
How EN 455‑1 fits the rest of the standard
EN 455-1 covers leakage only. The other parts cover the rest of the glove's performance, and a compliant product needs all of them:
EN 455-1 is widely referenced outside Europe as well, which is part of why it functions as common ground between buyers and manufacturers working in different regulatory systems.
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.
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