K210391 is an FDA 510(k) clearance for the Single-use medical face mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Zhuhai Herald Datanetics Limited. (Zhuhai, CN). The FDA issued a Cleared decision on July 22, 2021, 162 days after receiving the submission on February 10, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2021 |
| Decision Date | July 22, 2021 |
| Days to Decision | 162 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 |