OUK — Surgical Mask With Antimicrobial/Antiviral Agent Class II
FDA product code OUK covers "Surgical Mask With Antimicrobial/Antiviral Agent", a Class II medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OUK
- Device Class
- Class II
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231741 | prestige ameritech | ProGear® Surgical Mask with Oxafence®, Model AV82030 | September 5, 2024 |
| K192105 | innonix technologies limited | Innonix Antiviral Child's Face Mask | November 29, 2019 |
| K182766 | nbc meshtec | Cufitec Surgical Mask | January 3, 2019 |
| K101128 | filligent limited | BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF | May 26, 2011 |