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EN 455-1

EN 455-1

A medical glove quotation may bundle several different claims under “EN 455 compliant”. EN 455-1 concerns freedom from holes, one specific assessment area. For a buyer, the useful question is whether the supplier’s evidence relates to the glove model, materials and supply being proposed, alongside the other requirements relevant to that product.
Editorial guide Content updated 7 October 2026
On this page
  1. Edition and revision status
  2. Hole integrity is one part of the product review
  3. Connect the report to the supplied product
  4. A fictional distributor substitution
  5. Buy the right document and access
  6. Frequently asked questions
  7. Explore more standards buying guides

This guide helps select the document and prepare a focused supplier enquiry. It does not select gloves for a clinical task or reproduce sampling and acceptance rules.

Edition and revision status

EN 455-1:2020+A2:2024 is the published Genorma record checked on 7 October 2026. BSI lists its corresponding adoption as current. Genorma also records a revision stage; that is not a published replacement or proof of withdrawal. Genorma record; BSI catalogue.

Include the full amendment reference in the document order. Keep the exact editions named in supplier reports so a reviewer can identify any mismatch rather than relying on a generic series claim.

Hole integrity is one part of the product review

The public scope gives requirements and a test method for determining freedom from holes in medical gloves for single use. That is a narrower question than whether the product is suitable for every medical or protective task. Source: Genorma scope.

Distinguish the evidence areas in a medical glove purchase
AreaBuyer’s question
Freedom from holesWhich Part 1 evidence covers the specified glove?
Physical propertiesWhich separate evidence supports the material and physical claims?
Biological evaluationWhat product-specific assessment and information is available?
Shelf life and other claimsWhich evidence supports storage, expiry and any additional intended protection?

The EN 455 family guide explains the broader series. The table is an enquiry framework, not a complete conformity checklist.

Connect the report to the supplied product

Prepare a glove identity sheet recording manufacturer, product name and code, material, size range, relevant options, packaging version and intended claims. Distinguish the commercial distributor’s code from the manufacturer’s identification so the connection can be checked.

  • Report identity: does the evidence identify the actual manufacturer and glove model?
  • Product coverage: which materials, sizes or versions are covered, and how is that coverage explained?
  • Supply traceability: how are the delivery and batch identifiers connected to the product and production records?
  • Assessment basis: which exact edition, method and limitations appear in the report?
  • Changes: who reviews a different manufacturing site, formulation, construction or packaging claim?

These are original procurement questions. Obtain the actual sampling, method and acceptance requirements from the licensed document and have the competent reviewer determine their application. Do not infer a batch decision from a photograph of the box or a single isolated result.

Agree what evidence will accompany routine deliveries and what triggers a new review. Keeping the product identity, supplier response and unresolved questions in one record helps receiving teams detect changes that might otherwise be hidden by unchanged branding.

A fictional distributor substitution

A distributor proposes a replacement glove under its existing sales code. The carton design is similar, but the manufacturer and material description have changed. The supplier provides a hole-integrity report for the earlier product.

The buyer asks for a clear mapping between the new model and its evidence. The responsible reviewer considers Part 1 coverage alongside the other relevant product claims and requests missing information. The receiving specification is updated so the replacement can be distinguished from earlier stock.

The decision is to resolve evidence identity before accepting the substitution. This example is fictional and does not establish the suitability of either glove for patient care or hazardous substances.

Buy the right document and access

Confirm the full edition, language, format and permitted users with Genorma. If several staff need the document, clarify licence coverage. The seller confirms available options and the final checkout price.

View price and buy on Genorma

Frequently asked questions

Does Part 1 establish all glove performance?

No. Its scope is freedom from holes. Review the other relevant assessment areas and intended claims separately.

Can medical glove evidence replace evidence for chemical protection?

Do not infer additional protection from the medical-glove reference. Ask the responsible reviewer which framework and evidence fit the actual claim.

Is a revision stage a new edition?

No. Check for an actual published replacement and record the edition selected for the purchase.

Public primary sources checked on 7 October 2026. This guide supports document procurement and evidence enquiries, not clinical or regulatory approval.

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