K220191 is an FDA 510(k) clearance for the Disposable Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Jiujiang Taixin Technology Co., Ltd. (Jiujiang, CN). The FDA issued a Cleared decision on May 24, 2022, 120 days after receiving the submission on January 24, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K220191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2022 |
| Decision Date | May 24, 2022 |
| Days to Decision | 120 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 |