K202745 is an FDA 510(k) clearance for the Disposable medical face mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Ningbo Jingeao Electronics, Inc. (Cixi, CN). The FDA issued a Cleared decision on August 23, 2021, 339 days after receiving the submission on September 18, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202745 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2020 |
| Decision Date | August 23, 2021 |
| Days to Decision | 339 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 |