K201991 is an FDA 510(k) clearance for the Medical surgical mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Shenzhen Everwin Precision Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 23, 2020, 129 days after receiving the submission on July 17, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K201991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2020 |
| Decision Date | November 23, 2020 |
| Days to Decision | 129 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 |