K212205 is an FDA 510(k) clearance for the Medical Protective Masks. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Qinhuangdao Taizhi Medical Technology Co., Ltd. (Qinhuangdao, CN). The FDA issued a Cleared decision on October 14, 2021, 91 days after receiving the submission on July 15, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2021 |
| Decision Date | October 14, 2021 |
| Days to Decision | 91 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 |