K203534 is an FDA 510(k) clearance for the Surgical face mask (Model: Flat Ear Loop/CN102). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Crown Name Disposable Hygiene Products Fty., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on July 21, 2021, 231 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 | K203534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2020 |
| Decision Date | July 21, 2021 |
| Days to Decision | 231 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 |