Verify the certification file names the exact model before you compare prices
For the US market, confirm the gloves carry FDA 510(k) clearance; for other markets, confirm the relevant certification. The file must name the exact model you are ordering β a certificate that covers a similar but different glove is not proof your order is compliant. Check the issuing body, the standard it meets and the validity period, and keep a copy on file for your own customs and market-entry process. A supplier who cannot produce the file for the exact model should be treated as unverified, regardless of price.
- FDA 510(k) clearance for the US market
- The file must name the exact model you order
- Check the issuing body, standard and validity period
- A supplier without the exact-model file is unverified



