K202323 is an FDA 510(k) clearance for the Disposable Medical Surgical Masks. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on February 2, 2021, 169 days after receiving the submission on August 17, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202323 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2020 |
| Decision Date | February 02, 2021 |
| Days to Decision | 169 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 |