EN 455 explained: a practical guide for medical glove buyers
What each part of EN 455 covers, what AQL 1.5 means, and which documents to request before approving single-use medical gloves.
Published by NewGlove
Reviewed and updated 10 August 2026
EN 455 is a four-part European standard for single-use medical gloves. Buyers often see “EN 455” on a data sheet, but that shorthand can hide which tests were completed, which product and size were tested, and whether the evidence matches the glove being offered.
This guide is a procurement overview, not regulatory advice. The manufacturer’s intended use, declaration of conformity, labelling and current rules in the destination market should be reviewed alongside test reports.
What the four parts cover
Each part answers a different question. Conformity with one part should not be read as evidence for all four.
- EN 455-1 - freedom from holes: sampling and water-leak testing used to assess whether a production lot meets the stated acceptance quality limit (AQL).
- EN 455-2 - physical properties: dimensions and mechanical performance, including force at break, before and after accelerated ageing.
- EN 455-3 - biological evaluation: requirements covering matters such as test chemicals, endotoxins for sterile gloves, powder residue and latex-protein information where relevant.
- EN 455-4 - shelf life: evidence used to support the labelled shelf life and storage information.
What AQL 1.5 actually tells you
AQL is a statistical lot-acceptance measure, not a promise that every glove is defect-free. An AQL of 1.5 is used with a defined sampling plan: inspectors test a sample from a production lot and accept or reject that lot against the permitted number of nonconforming units.
For buyers, the useful questions are practical: which edition of EN 455-1 was used, what AQL was declared, which lot and sizes the report covers, and whether the report can be matched to the delivered product. NewEvo+300 lists freedom from holes at AQL 1.5; request the current specification and supporting documents for the exact SKU you are assessing.
EN 455 does not cover every risk
EN 455 is for medical gloves. A glove intended to protect the wearer from dangerous chemicals or microorganisms may also sit within PPE rules and require evidence against the relevant EN ISO 374 standards. A glove’s material or colour does not establish chemical suitability.
Check the stated intended use and the chemical permeation, penetration and degradation data relevant to your task. Do not infer protection against a particular chemical from a Type A, B or C label alone.
A buyer’s document checklist
Before approving a medical examination glove, ask the supplier for a coherent, current document pack.
- Product specification and current instructions or information supplied with the glove.
- Declaration of conformity identifying the exact product and applicable legislation.
- EN 455 reports or certification scope, with part numbers, editions, test dates and product references visible.
- Lot or batch traceability that connects cartons and delivery paperwork to quality records.
- Shelf-life and storage information, plus confirmation that the remaining shelf life fits your stock rotation.
- Additional PPE and chemical-resistance evidence where the intended task requires wearer protection.
How NewGlove can help
NewGlove’s NewEvo+300 product specification lists EN 455 Parts 1–4, AQL 1.5 and a three-year shelf life from manufacture. Because suitability depends on the use case and destination market, the next step is to review the exact SKU, documentation and application together - not to select on a logo alone.