K213920 is an FDA 510(k) clearance for the Kangbeier Surgical Mask (Model: KBR-1001). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Xinxiang Kangbeier Medical Technology Co., Ltd. (Changyuan, CN). The FDA issued a Cleared decision on January 16, 2022, 32 days after receiving the submission on December 15, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K213920 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2021 |
| Decision Date | January 16, 2022 |
| Days to Decision | 32 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 |