K203704 is an FDA 510(k) clearance for the Surgical face mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Juntech(Jiaxing)Healthcare Materials Co,.Ltd (Jiaxing, CN). The FDA issued a Cleared decision on June 4, 2021, 168 days after receiving the submission on December 18, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K203704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2020 |
| Decision Date | June 04, 2021 |
| Days to Decision | 168 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 |