K192362 is an FDA 510(k) clearance for the Aero Blue Performance Surgical Gowns. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on December 13, 2019, 105 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 | K192362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2019 |
| Decision Date | December 13, 2019 |
| Days to Decision | 105 days |
| Submission Type | Abbreviated |
| 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 |