K210643 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 August 4, 2021, 154 days after receiving the submission on March 3, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2021 |
| Decision Date | August 04, 2021 |
| Days to Decision | 154 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 |