K211165 is an FDA 510(k) clearance for the Medical Face Masks, Model Name:MY020003. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Huizhou Jie Bai Purification Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on November 9, 2021, 204 days after receiving the submission on April 19, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211165 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2021 |
| Decision Date | November 09, 2021 |
| Days to Decision | 204 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 |