K201852 is an FDA 510(k) clearance for the Surgical Mask-Model Number: Ear Loop, Flat-Pleated. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on March 2, 2021, 239 days after receiving the submission on July 6, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K201852 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2020 |
| Decision Date | March 02, 2021 |
| Days to Decision | 239 days |
| Submission Type | Abbreviated |
| 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 |