Disposable Glove Standards Explained: EN455, ASTM, EN ISO 374 and AQL
If you import disposable examination or industrial gloves, four standards and one sampling rule decide whether a supplier’s product is compliant: EN 455 (medical gloves, EU), ASTM D6319 / D5250 (US disposable examination gloves), EN ISO 374 (chemical & micro-organizational protection) and AQL acceptable quality level sampling. As a manufacturer running its own testing, Zhanjiang Jiali Glove Products explains what each one actually verifies.
EN 455 — medical examination gloves (EU)
EN 455 is the European harmonized standard for single-use medical gloves, in four parts:
- EN 455-1 — Freedom from holes. Water-fill (leak) test on an AQL-sampled batch; the batch must meet the acceptable quality level for pinholes.
- EN 455-2 — Physical properties. Tensile strength and force-at-break, before and after accelerated ageing.
- EN 455-3 — Biomedical evaluation. Biocompatibility: cytotoxicity, sensitisation and skin irritation.
- EN 455-4 — Shelf life. Determination of shelf life through accelerated ageing.
ASTM D6319 and D5250 — US market
For the United States, ASTM D6319 is the standard specification for disposable nitrile gloves and ASTM D5250 covers natural rubber latex disposable examination gloves. Both define physical-property and freedom-from-hole testing. Examination gloves sold in the US additionally require FDA 510(k) clearance as a Class II medical device under 21 CFR 880.6250.
EN ISO 374 — chemical and micro-organism protection
Where gloves are PPE against chemicals or micro-organisms (industrial and Category III uses), the EN ISO 374 series applies, classifying gloves into Types A, B and C by the number of chemicals resisted through permeation testing, each chemical assigned a degradation/permeation level. CE Category III gloves must be EU-type examined by a Notified Body.
AQL — acceptable quality level sampling
AQL is the maximum number of defects a batch can contain and still be accepted, sampled per ISO 2859-1 / ANSI-ASQ Z1.4. In glove manufacturing the common levels are AQL 1.5 for freedom from holes and looser levels (for example AQL 4.0) for cosmetic/aesthetic defects. Lower AQL = stricter sampling = fewer defective gloves reaching you.
Powder-free vs powdered
Powdered gloves used cornstarch to ease donning, but powder can carry proteins and irritate wounds and airways; powder-free gloves (polymer-coated or chlorinated interiors) are now the standard for examination and food use. All Jiali examination gloves are available powder-free.
How Jiali demonstrates compliance
Our examination and industrial lines carry CE EU-type examination certificates (Notified Body 0075, CTC Groupe) at Category II and Category III, and FDA 510(k) K072145 for patient examination gloves, under an ISO 9001:2015 quality system with amfori BSCI social audit. Exact certificate numbers are published on our certifications page for verification.
FAQ
What is EN 455? The European standard for single-use medical gloves, covering freedom from holes (455-1), physical properties (455-2), biocompatibility (455-3) and shelf life (455-4).
What AQL do disposable gloves use? Typically AQL 1.5 for freedom from holes, with looser cosmetic levels such as AQL 4.0.
Do disposable nitrile gloves need FDA clearance? Nitrile examination gloves sold in the US require FDA 510(k) clearance; ASTM D6319 governs the physical specification.
OEM & private-label or contact us for compliance documentation.