K212826 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 Jiangsu Nanfang Medical Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on January 19, 2022, 138 days after receiving the submission on September 3, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212826 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2021 |
| Decision Date | January 19, 2022 |
| Days to Decision | 138 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 |