K192374 is an FDA 510(k) clearance for the Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on December 2, 2019, 94 days after receiving the submission on August 30, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K192374 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2019 |
| Decision Date | December 02, 2019 |
| Days to Decision | 94 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 |