What a glove certificate actually covers
FDA, CE, EN455 and ASTM D6319 are not interchangeable, and a certificate that names the wrong one is no certificate at all.
FDA listing is not FDA clearance
A device establishment registration and device listing means the manufacturer has told the FDA it exists and what it makes. A 510(k) clearance is a substantive review against a predicate device. Both appear in this catalogue against different gloves, and they are not equivalent — check which one your buyer actually requires.
EN455 is a four-part standard
EN455 covers medical gloves for single use: freedom from holes, physical properties, biological evaluation, and shelf-life determination. A claim of "EN455" without a part number is incomplete; ask which parts the test report covers.
ASTM D6319 is the nitrile examination specification
It sets dimensions, tensile strength and freedom-from-holes requirements specifically for nitrile examination gloves. It is the standard a North American clinical tender is most likely to name.
EN374 is chemical, not medical
EN374 covers protective gloves against dangerous chemicals and micro-organisms. It answers a different question from EN455 and appears against the wholesale stock lines here. If your risk is solvent contact rather than infection, this is the one that matters.
Tie the certificate to the line and the date
Certificates attach to a product made in a particular factory in a particular period. Ask for the report against the exact line you are buying, with the issue date, and check the two match your order.
Where this applies in the catalogue
The guidance above is general. Applied here, it lands hardest on the disposable gloves family.
