What we know about gloves, standards and safe supply.
Written by our own specialists for the people who write specifications: procurement officers, infection-control staff and quality managers. No marketing claims – standards, test methods and what they mean in practice.
What documentation to demand from a PPE supplier
A certificate states a conclusion. A test report shows what was tested, by whom, against which clause, and what happened. What to demand from a PPE supplier, in what order, how to check a notified body is real and in scope, and why the edition on the certificate matters more than the certificate.


A certificate states a conclusion. A test report shows what was tested, by whom, against which clause, and what happened. What to demand from a PPE supplier, in what order, how to check a notified body is real and in scope, and why the edition on the certificate matters more than the certificate.

WHO, CDC, ECDC and MSF each publish a position on filovirus PPE, and they disagree on the respirator, the coverall and the doffing protocol. What each one actually says, why humanitarian specifications name more than one conformity framework, and what a specification has to state to mean anything.

A glove tender is decided when the specification is written. Which standards to cite and in which editions, how to specify AQL, what documentation to require, and how to write award criteria that can actually be evaluated.

The newest part of EN 455 standardises how chemical residues in gloves are measured, replacing plain-water extraction with 75 % ethanol. What it covers, what it deliberately does not, and how to specify it.

An LCA is the only credible way to compare two gloves, and it is easy to construct one that flatters a product entirely within the rules. Check the boundaries before the number.

Accelerators give a glove its strength and elasticity, and cause roughly 80 % of glove-related contact allergy. Which families are used, and why a glove labelled "accelerator-free" may not be.

Double gloving reliably protects the surgical team. Whether it reduces patient infection rates is a separate and much weaker claim, and the two are routinely merged.

Awarded July 2024 for sterile surgical gloves to the region’s hospitals – and, when the named manufacturer closed in 2026, a test of whether continuity had been planned for.

Most MDR guidance is written for implant manufacturers. This covers gloves: how they are classified, what a notified body actually checked, and the documents to ask a supplier for.

A shelf-life claim is a tested statement. Accelerated ageing supports three years; five years needs real-time data – and the glove must still pass parts 1 and 2 at the end of it.

Two suppliers can both hold a valid test report and quote figures that cannot be compared. The method and duration matter more than the percentage.

The 2023 revision makes chemical disclosure explicit. Endotoxin, powder and protein limits, the ISO 10993 link, and why "accelerator-free" now needs evidence.

Three disruptions in under three years, each hitting glove supply by a different mechanism – freight cost, then raw material cost and manufacturer solvency.

Part two governs how a glove fits and whether it holds: median dimensions per size and force at break per material, tested before and after ageing. What to require in a tender.

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.

Most guidance lists glove types. The decision actually runs the other way: sterility, exposure, wear duration, sensitivity – then the product.

Shelf life is a tested figure, and it is conditional on storage. Store gloves outside the declared conditions and the compliance claim no longer covers them.

The US specification for nitrile examination gloves, and the one difference that matters in a tender: ASTM accepts AQL 2.5 where EN 455-1 requires 1.5.

EN ISO 374 is five separate standards, not one, and "EN 374 certified" on its own is unverifiable. What each part covers, how to read Type A/B/C and the code letters, and what to write into a specification.

Five parts, five different questions. What each part of the European medical glove standard governs, what "EN 455 compliant" actually tells you, and what to require in a tender.

“Biodegradable” is one of the least regulated words in glove marketing. What the claim rests on, our tested figures, and five questions that separate testing from marketing.

The glass-and-fork symbol certifies chemical migration under the conditions tested – not cleanliness, and not unconditionally. The correct legal basis for rubber gloves, the six simulants, and the gap to check.

A glove that arrives carrying a microbial load is a vector, not a barrier. No declaration on a non-sterile glove covers this, so it has to be asked for.

For a company sourcing gloves from Asia and supplying public healthcare, this was less about signalling values than accepting a documented obligation where it is hardest to meet.

The D-terms put the seller in charge of the whole journey. The differences come down to who unloads and who pays import duty – and DDP has a VAT problem.

CIF and CIP look interchangeable and are not. Since 2020 they require different levels of insurance, and for palletised cargo the difference decides whether damage is covered.

The two terms most often quoted on a glove price, and the two most often quoted wrongly. What each actually obliges, and why an EXW price is not comparable to a delivered one.

Nitrile is the right laboratory default, and it is routinely credited with solvent resistance it does not have. What the breakthrough data actually shows.

Two gloves can meet the same standard and feel completely different. Usually the difference is modulus – the property no medical glove standard requires anyone to declare.

"AQL 1.5" is the most misunderstood number in the trade. It does not mean 1.5 % of gloves leak, and on a non-medical box it may mean nothing at all.

Almost every property on a glove datasheet is determined at a specific point on the dipping line. When a batch fails, the failure has an address.

Latex has retreated further from European healthcare than the evidence justifies. Where it is still the better material, and where it is not.

Nitrile arrived late and took a decade to be accepted. The 1990 patent that created the industry claimed comfort, not strength.

Three materials account for almost all single-use glove supply, and they are not interchangeable. What actually separates them, and what to specify.

Danish healthcare publication MedWatch reported on the launch in June 2022, putting Scandinavian market potential at DKK 100–200 million.

The first biodegradable nitrile glove on the Scandinavian market to hold full medical certification – with a correction to a figure in the original announcement.

Awarded March 2022 against larger established European brands, and delivered by June. What a million-box award actually tests.
The EN 455 series, part by part.
The European standard for single-use medical gloves runs to five parts plus an introduction. Each is covered in its own article – the reference set behind every specification we quote against.
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