K230838 is an FDA 510(k) clearance for the Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on July 27, 2023, 122 days after receiving the submission on March 27, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K230838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2023 |
| Decision Date | July 27, 2023 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |