Skip to content

Independent standards discovery and compliance platform

How we work
European standard guide European standard guide

EN 455-4

EN 455-4

EN 455-4 is the shelf-life document for single-use medical gloves. Its buyer question has two parts: what supports the manufacturer's stated shelf life, and how much usable shelf life the supply contract should leave on delivery. The first is a technical evidence question. The second is a commercial requirement that purchasing must state clearly rather than assume from an expiry date.
Editorial guide Content updated 7 October 2026
On this page
  1. Published document and revision status
  2. Keep technical and delivery requirements separate
  3. Connect the product file to the supply chain
  4. Questions before a framework order
  5. A fictional delivery decision
  6. View the shelf-life document
  7. Common buying questions
  8. Explore more standards buying guides

Published document and revision status

Genorma lists EN 455-4:2009 as published, with revision work in development. The EVS catalogue independently identifies the published European reference. A recent revision-project date does not make a new published edition available. Confirm the status again at purchase and use the reference selected by the responsible technical reviewer.

The public scope addresses shelf-life requirements, associated labelling and information, including new and significantly changed designs. It does not supply the buyer's delivery schedule or stock-rotation policy. This guide does not reproduce ageing methods or calculate an expiry date.

Keep technical and delivery requirements separate

Four distinct shelf-life questions in a supply contract
QuestionEvidence or agreement neededPurchasing action
What supports the claimed shelf life?Product-specific technical evidence.Refer the manufacturer's rationale to the technical reviewer.
What storage conditions apply?Information for the actual product and packaging.Connect the instructions to warehousing and delivery responsibilities.
What time should remain at receipt?An explicit commercial acceptance condition.State the requirement in the order without inventing a standard limit.
Which delivered stock does the information cover?Traceable product, batch and expiry identification.Match received goods to the accepted product and documentation.

A supplier may quote a total shelf life while a customer needs a minimum remaining period on receipt. These are different quantities. Ask the commercial team to set the delivery condition with the responsible users and stock planners, then make it visible in the tender and acceptance process. This guide provides no recommended number of months; the appropriate contract condition depends on the actual supply and use plan.

Request an explanation of evidence coverage for the exact glove and packaging offered. A report on an earlier construction or packaging arrangement should be referred to the technical reviewer before it is reused for a changed product. The buyer's role is to make the change visible and obtain an answer, not to extrapolate ageing performance from a similar product name.

Connect the product file to the supply chain

Ask for the manufacturer's storage information and identify who is responsible for communicating it to warehouses and transport providers. If an offer includes stock already held by a distributor, request the identification needed to relate it to the accepted product and stated expiry. A spreadsheet of dates is easier to use when product and batch identifiers are consistent across the commercial and technical records.

Agree how nonconforming deliveries will be handled under the purchasing contract. If the remaining period falls below the agreed condition, the commercial process should identify who can reject, replace or refer the delivery for review. Do not let the receiving team create an informal extension of the manufacturer's expiry information to solve a stock problem.

Shelf-life evidence also belongs beside the other glove evidence. Use the medical-glove family guide to keep freedom from holes, physical properties and biological-evaluation questions distinct. The responsible reviewer should select the wider assessment set; a Part 4 reference alone does not settle the product's complete technical or regulatory status.

Questions before a framework order

  • Does the shelf-life evidence represent the exact glove construction and packaging being supplied?
  • What storage information applies, and who communicates it through the supply chain?
  • What remaining period on receipt has the purchaser explicitly agreed?
  • How will product, batch and expiry identifiers be checked on delivery?
  • What review is triggered by a changed design, packaging arrangement or proposed expiry claim?

A fictional delivery decision

A distributor offers discounted gloves with a stated manufacturer expiry date. A clinic's contract requires a particular remaining period at receipt, but the quotation mentions only the total shelf life. The buyer is asked to accept the shipment because it is technically unexpired.

The purchasing team checks the explicit delivery condition and obtains batch and expiry information before acceptance. It keeps the manufacturer's technical shelf-life claim separate from the contract's remaining-period requirement. This fictional example supplies no acceptable expiry period and makes no recommendation to use a particular batch.

View the shelf-life document

View price and buy on Genorma

Confirm publication status, language, document licence and seller's checkout terms before purchase.

Common buying questions

Does the standard set our delivery deadline?

Define the commercial remaining-period condition in the order. Do not infer your contract terms from a standard title.

Can we extend an expiry date ourselves?

Do not substitute a local commercial decision for the manufacturer's supported product information. Refer the question to the responsible technical team and supplier.

Is the revision project a new edition?

Development status is different from publication. Check the exact record before buying.

Public catalogue sources and purchase record checked on 7 October 2026.

Explore more standards buying guides

Browse standards by reference and subject to compare related document choices.

From reading to action

Need help interpreting, implementing or testing against this standard?

Describe the product, organisation, target market and decision you need to make. We will direct you to the most relevant guide or specialist route available on the platform.

Describe your project