K210302 is an FDA 510(k) clearance for the Disposable Medical mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Anhui Jbh Medical Apparatus Co., Ltd. (Chuzhou, CN). The FDA issued a Cleared decision on May 14, 2021, 100 days after receiving the submission on February 3, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2021 |
| Decision Date | May 14, 2021 |
| Days to Decision | 100 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 |