K213450 is an FDA 510(k) clearance for the Medical surgical mask (Black mask, Level 1 and Level 3). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Guangdong Kingfa Sci. & Tech.Co., Ltd. (Qingyuan City, CN). The FDA issued a Cleared decision on April 5, 2022, 161 days after receiving the submission on October 26, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K213450 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2021 |
| Decision Date | April 05, 2022 |
| Days to Decision | 161 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 |