K230569 is an FDA 510(k) clearance for the Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on July 3, 2023, 124 days after receiving the submission on March 1, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K230569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2023 |
| Decision Date | July 03, 2023 |
| Days to Decision | 124 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXX — Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |