K203528 is an FDA 510(k) clearance for the KNH Surgical Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Knh Surgical Face Mask (Tainan, TW). The FDA issued a Cleared decision on November 16, 2022, 714 days after receiving the submission on December 2, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K203528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2020 |
| Decision Date | November 16, 2022 |
| Days to Decision | 714 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 |