K200522 is an FDA 510(k) clearance for the AERO CHROME* Breathable 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 March 16, 2020, 14 days after receiving the submission on March 2, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K200522 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2020 |
| Decision Date | March 16, 2020 |
| Days to Decision | 14 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 |