K201622 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 Guangdong Kingfa Sci. & Tech.Co., Ltd. (Qingyuan, CN). The FDA issued a Cleared decision on November 24, 2020, 162 days after receiving the submission on June 15, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K201622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2020 |
| Decision Date | November 24, 2020 |
| Days to Decision | 162 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 |