FDA product code OUK: Surgical Mask With Antimicrobial/Antiviral Agent
OUK is the FDA product code for surgical mask with antimicrobial/antiviral agent. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. FDA has cleared 4 510(k) submissions under OUK, 1 in the last five years, from 4 different applicants. The average 510(k) review took 265 days (median 258); 449 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Surgical Mask With Antimicrobial/Antiviral Agent |
| Device class | Class II |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for OUK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 106 |
| 2024 | 1 | 449 |
Compare with all 510(k) review times · Search every OUK clearance
Top OUK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Prestige Ameritech | 1 | 2024-09-05 |
| Innonix Technologies Limited | 1 | 2019-11-29 |
| Nbc Meshtec, Inc. | 1 | 2019-01-03 |
| Filligent Limited | 1 | 2011-05-26 |
Most recent OUK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231741 | Prestige Ameritech | ProGear® Surgical Mask with Oxafence®, Model AV82030 | 2024-09-05 | 449 |
| K192105 | Innonix Technologies Limited | Innonix Antiviral Child's Face Mask | 2019-11-29 | 116 |
| K182766 | Nbc Meshtec, Inc. | Cufitec Surgical Mask | 2019-01-03 | 97 |
| K101128 | Filligent Limited | BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013 | 2011-05-26 | 399 |
Recalls for OUK devices
openFDA lists no recalls for product code OUK.
Frequently asked questions
What is FDA product code OUK?
OUK is the FDA product code for surgical mask with antimicrobial/antiviral agent. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is OUK?
Class II, regulation 21 CFR 878.4040. Typical premarket route: 510(k).
How long does a 510(k) take for product code OUK?
Across 4 cleared submissions the average was 265 days from receipt to decision (median 258).
Which companies have the most OUK clearances?
Prestige Ameritech (1); Innonix Technologies Limited (1); Nbc Meshtec, Inc. (1); Filligent Limited (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OUK
- Run a recall and safety report across every OUK manufacturer
- Watch product code OUK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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