K201974 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 Guangdong Horigen Mother & Baby Products Co., Ltd. (Shantou, CN). The FDA issued a Cleared decision on March 7, 2021, 235 days after receiving the submission on July 15, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K201974 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2020 |
| Decision Date | March 07, 2021 |
| Days to Decision | 235 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 |