K203200 is an FDA 510(k) clearance for the Disposable Medical Surgical Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Guangdong Haiou Medical Apparatus Co., Ltd. (Puning, CN). The FDA issued a Cleared decision on June 16, 2021, 230 days after receiving the submission on October 29, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K203200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2020 |
| Decision Date | June 16, 2021 |
| Days to Decision | 230 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 |