OUKClass II
Surgical Mask With Antimicrobial/Antiviral Agent
21 CFR 878.4040 / General, Plastic Surgery
OUK is the FDA product code for Surgical Mask With Antimicrobial/Antiviral Agent, a class II device type, regulated under 21 CFR 878.4040. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OUK
- Device name
- Surgical Mask With Antimicrobial/Antiviral Agent
- 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.
- Regulation
- 21 CFR 878.4040
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code OUK
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2019 | 2 |
| 2024 | 1 |
Applicants with the most clearances
Product code OUK| Applicant | Clearances |
|---|---|
| Filligent Limited | 1 |
| Innonix Technologies Limited | 1 |
| Nbc Meshtec, Inc. | 1 |
| Prestige Ameritech | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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