When sourcing surgical gloves for the US market, buyers will see “FDA 510(k) cleared” on many supplier websites. But what does 510(k) actually mean, and why does it matter?
What Is FDA 510(k)?
510(k) is the FDA’s premarket notification pathway for medical devices that are substantially equivalent to a legally marketed predicate device. For sterile surgical gloves, clearance under 510(k) means the FDA has determined the device is as safe and effective as an existing legally marketed product.
510(k) is not the same as FDA “approval” — that term is reserved for higher-risk devices that require Premarket Approval (PMA). Surgical gloves go through the 510(k) pathway.
What HBM's FDA 510(k) Covers
HBM Protections holds FDA 510(k) clearance for Medispo surgical gloves:
Item | Detail |
|---|---|
510(k) Number | K203483 |
Trade/Device Name | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves |
Regulation | 21 CFR 878.4460 (Non-Powdered Surgeon's Glove) |
Product Code | KGO |
Regulatory Class | Class I, reserved |
Decision Date | November 19, 2020 |
This clearance covers both natural rubber latex and polyisoprene sterile surgical gloves.
Why 510(k) Matters for US Buyers
For US hospitals, distributors and importers:
- 510(k) clearance is required to market sterile surgical gloves in the United States
- The cleared device type matches what is actually sold — buyers should verify that the specific glove model they are ordering is covered by the clearance
- Request the 510(k) letter and check the device name matches the product you are sourcing
What 510(k) Does Not Cover
510(k) clearance is product-specific. It does not automatically cover every glove type a manufacturer produces. Buyers should:
- Confirm the exact glove model and material covered by the clearance
- Request the 510(k) summary or letter
- Check that the manufacturer’s registration and listing are current
Request the 510(k) Letter
Contact our team to request a copy of the FDA 510(k) clearance letter (K203483) for Medispo rubber and polyisoprene surgical gloves.
