K202843 is an FDA 510(k) clearance for the Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. (Beijing, CN). The FDA issued a Cleared decision on January 12, 2021, 109 days after receiving the submission on September 25, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2020 |
| Decision Date | January 12, 2021 |
| Days to Decision | 109 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 |