K210181 is an FDA 510(k) clearance for the Nordiwell Surgical Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Changzhou Combat Protective Equipment Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on March 9, 2021, 46 days after receiving the submission on January 22, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2021 |
| Decision Date | March 09, 2021 |
| Days to Decision | 46 days |
| Submission Type | Special |
| 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 |