K202310 is an FDA 510(k) clearance for the Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back. This device is classified as a Gown, Isolation, Surgical (Class II - Special Controls, product code FYC).
Submitted by Wildcat Ppe, LLC (Conroe, US). The FDA issued a Cleared decision on January 29, 2021, 168 days after receiving the submission on August 14, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2020 |
| Decision Date | January 29, 2021 |
| Days to Decision | 168 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 |