K212460 is an FDA 510(k) clearance for the Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Guangzhou Zhengkang Medical Equipment Co.,Ltd (Guangzhou, CN). The FDA issued a Cleared decision on November 5, 2021, 92 days after receiving the submission on August 5, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2021 |
| Decision Date | November 05, 2021 |
| Days to Decision | 92 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 |