K203078 is an FDA 510(k) clearance for the CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Huizhou Tianchang Industrial Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on August 19, 2022, 675 days after receiving the submission on October 13, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K203078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 2020 |
| Decision Date | August 19, 2022 |
| Days to Decision | 675 days |
| Submission Type | Abbreviated |
| 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 |