K202358 is an FDA 510(k) clearance for the Protective Face Mask for Medical Use. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Hunan Heng Chang Pharmaceutical Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on January 29, 2021, 163 days after receiving the submission on August 19, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2020 |
| Decision Date | January 29, 2021 |
| Days to Decision | 163 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 |