K242502 is an FDA 510(k) clearance for the Aurelia Surgical Mask ASTM Level-3 (2130). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Supermax Healthcare Canada-Supermax Medical (Saint-Bruno-De-Montarville, CA). The FDA issued a Cleared decision on November 12, 2024, 82 days after receiving the submission on August 22, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K242502 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2024 |
| Decision Date | November 12, 2024 |
| Days to Decision | 82 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 |