Which registration belongs to which product
FDA, CE, ANVISA, ASTM, EN and ISO all appear across this range — but never all on the same product. This page keeps them apart, because that is how a tender reads them.
Supplier certification pages usually show a wall of logos and leave the buyer to assume everything applies to everything. It does not. Below is the certification each published product line actually carries.
By product line
| Product | Family | Standards & certification |
|---|---|---|
| Disposable Nitrile Examination Glove | Disposable Gloves | FDA-510K, ASTM D6319, EN455 |
| Powder Free Disposable Nitrile Glove | Disposable Gloves | FDA listing |
| Disposable Latex Exam Glove | Disposable Gloves | CE |
| Disposable Vinyl Exam Glove | Disposable Gloves | FDA |
| Disposable Syringe Needle | Syringes & Needles | CE, FDA, ANVISA |
| Disposable Surgical Face Masks (3-ply, non-sterile) | Disposable Masks | Stated in the product description |
| Disposable Medical Face Masks (3-ply, non-sterile) | Disposable Masks | Stated in the product description |
| Disposable Civilian Protective Face Masks (3 Layered) | Disposable Masks | Stated in the product description |
Standards published against the US warehouse stock
The wholesale page lists a further set of standards against the lines held in US warehouses. They are reproduced here as published.
| Stock line | Standards | Registration |
|---|---|---|
| Nitrile exam gloves (US stock) | ISO 10993, EN374, EN455, EN420, ASTM D6319 | FDA / 510K / CE registered |
| Blend nitrile gloves (US stock) | ISO 9001-2016, EN455, EN374, EN16523 | FDA / 510K / CE registered |
| Vinyl gloves (US stock) | ISO 9001:13485, EN455, EN374 | FDA registered, 510K |
Scans as published by the company
These are the certificate images from the company’s own certifications page. Certificate numbers and issue dates were never published as text, so they are not reproduced here — ask for them in writing.
What to ask for, and what not to accept
- A test report, not a certificate pack. Ask for the third-party report against the exact line you are buying, with its issue date. The old FAQ names SGS as the body engaged to testify to legality and conformity.
- The part number on EN455. EN455 has four parts covering holes, physical properties, biological evaluation and shelf life. “EN455” on its own is incomplete.
- The difference between FDA listing and 510(k). A listing is a notification; a 510(k) is a substantive clearance. Both appear in this catalogue, against different gloves.
- Registration per destination. ANVISA for Brazil, CE for the EU, FDA for the US. A product cleared for one is not thereby cleared for another.
The CDC also runs an International Respirator Assessment that evaluates imported respirators on request from agencies, employers and healthcare systems — an independent route the old FAQ pointed to directly.
Need the documents for a tender?
Name the product line and the standard your tender specifies, and ask for the test report by date. That is a faster route than a generic certificate pack.