K210524 is an FDA 510(k) clearance for the Surgical Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Changzhou Holymed Products Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on July 7, 2021, 134 days after receiving the submission on February 23, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210524 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2021 |
| Decision Date | July 07, 2021 |
| Days to Decision | 134 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 |