A row of standards on a box looks like reassurance. It is more useful than that — each one answers a specific question about the glove in your hand. Here is what they actually cover.
EN 455 — the glove itself
The European standard for single-use medical gloves, written in four parts. Together they describe a glove that is intact, strong, safe against the skin, and honest about how long it lasts.
| EN 455-1 | Freedom from holes — the watertight test on every batch |
|---|---|
| EN 455-2 | Physical properties — dimensions and force at break |
| EN 455-3 | Biological evaluation — powder and protein limits, labelling |
| EN 455-4 | Shelf life — how the expiry date was determined, not assumed |
ASTM — the material specification
The American standards are material-specific, which makes them a quick way to confirm you are comparing like with like.
| ASTM D3577 | Rubber surgical gloves |
|---|---|
| ASTM D3578 | Rubber examination gloves — natural latex |
| ASTM D6319 | Nitrile examination gloves |
| ASTM D5151 | Detection of holes — the test method itself |
ISO 13485 — the factory
The others describe the product. This one describes the quality management system that produced it: documented processes, traceability from raw material to finished box, and audits that verify the system is followed rather than merely written down.
It is the difference between a good batch and a repeatable one. A glove can pass a test by luck once. It cannot pass an ISO 13485 audit by luck.
What to ask a supplier
Which AQL
and is it applied to every line
Which standards
matched to the actual material
Batch documentation
test records available on request
Certified manufacturing
ISO 13485, current and verifiable
Where BerrySure stands
Every line is made under ISO 13485 certified manufacturing and tested to AQL 1.5, against EN 455 and the ASTM standard matching the material — D3577 for surgical, D3578 for latex examination, D6319 for nitrile examination.
Ask for the documents. A supplier who has them will send them.