K202899 is an FDA 510(k) clearance for the Procedure Mask, Surgical Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Kenpax International Limited (Hong Kong, CN). The FDA issued a Cleared decision on May 20, 2021, 233 days after receiving the submission on September 29, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202899 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2020 |
| Decision Date | May 20, 2021 |
| Days to Decision | 233 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 |