K203388 is an FDA 510(k) clearance for the Disposable medical mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Everwin Toys (Dongguan)., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on June 4, 2021, 198 days after receiving the submission on November 18, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K203388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2020 |
| Decision Date | June 04, 2021 |
| Days to Decision | 198 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 |