K210860 is an FDA 510(k) clearance for the Comfort Guard Mask, level 1, Comfort Guard Mask, level 3. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Gri-Alleset, Inc. (Flowery Branch, US). The FDA issued a Cleared decision on April 7, 2022, 380 days after receiving the submission on March 23, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210860 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2021 |
| Decision Date | April 07, 2022 |
| Days to Decision | 380 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |