K203455 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 Fujian Kang Chen Daily Necessities Co., Ltd. (Quanzhou, CN). The FDA issued a Cleared decision on September 13, 2021, 294 days after receiving the submission on November 23, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K203455 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2020 |
| Decision Date | September 13, 2021 |
| Days to Decision | 294 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 |