K220876 is an FDA 510(k) clearance for the AOK 95A Medical Mask (20200049). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Aok Tooling Limited (Cheung Sha Wan, Kowloon, CN). The FDA issued a Cleared decision on July 27, 2022, 124 days after receiving the submission on March 25, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K220876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2022 |
| Decision Date | July 27, 2022 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |