K162930 is an FDA 510(k) clearance for the Aero Chrome* Select Breathable Performance Surgical Gowns. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Halyard Health, Inc. (Alpharetta, US). The FDA issued a Cleared decision on April 21, 2017, 184 days after receiving the submission on October 19, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K162930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2016 |
| Decision Date | April 21, 2017 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |