K210409 is an FDA 510(k) clearance for the Disposable Surgical Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Shandong Zhushi Pharmaceutical Group Co., Ltd. (Heze, CN). The FDA issued a Cleared decision on July 28, 2021, 167 days after receiving the submission on February 11, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2021 |
| Decision Date | July 28, 2021 |
| Days to Decision | 167 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 |