OUK
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Surgical Mask With Antimicrobial/Antiviral Agent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Medical specialty
- General, Plastic Surgery
- FDA definition
- A single use, disposable surgical mask for occupational use to cover the nose and mouth of the wearer to protect from the transfer of microorganisms,body fluids and particulates and has an added antimicrobial and/or antiviral agent which kills specific pathogens under specified contact conditions.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ProGear® Surgical Mask with Oxafence®, Model AV82030 (K231741) | Prestige Ameritech | 2024-09-05 |
| Innonix Antiviral Child's Face Mask (K192105) | Innonix Technologies Limited | 2019-11-29 |
| Cufitec Surgical Mask (K182766) | Nbc Meshtec, Inc. | 2019-01-03 |
| BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013 (K101128) | Filligent Limited | 2011-05-26 |
Track OUK automatically
Every clearance here is in the API, with alerts when new ones post.