K160339 is an FDA 510(k) clearance for the Cardinal Health Isolation Gown. This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on July 28, 2016, 171 days after receiving the submission on February 8, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K160339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2016 |
| Decision Date | July 28, 2016 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYC — Gown, Isolation, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |