K212863 is an FDA 510(k) clearance for the Surgical Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Taiwan Comfort Champ Manufacturing Co., Ltd. (Taoyuan City, TW). The FDA issued a Cleared decision on February 19, 2022, 164 days after receiving the submission on September 8, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K212863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2021 |
| Decision Date | February 19, 2022 |
| Days to Decision | 164 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 |