K202107 is an FDA 510(k) clearance for the Medical Protective 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 City, CN). The FDA issued a Cleared decision on January 15, 2021, 170 days after receiving the submission on July 29, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2020 |
| Decision Date | January 15, 2021 |
| Days to Decision | 170 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 |