K201893 is an FDA 510(k) clearance for the Disposable Surgical Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Xiamen Probtain Medical Techology Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on December 9, 2020, 154 days after receiving the submission on July 8, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K201893 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2020 |
| Decision Date | December 09, 2020 |
| 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 |