K211249 is an FDA 510(k) clearance for the Altor Safety 3-Ply Surgical Mask (Model:62222). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Altor Safety, LLC (Valley Cottage, US). The FDA issued a Cleared decision on July 23, 2021, 88 days after receiving the submission on April 26, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2021 |
| Decision Date | July 23, 2021 |
| Days to Decision | 88 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 |