# K202310: Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back

- Pathway: 510(k) (Traditional)
- Applicant: Wildcat Ppe, LLC
- Decided: Jan 29, 2021 after 168 days
- Product code: FYC (Gown, Isolation, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K952116 (1995). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160339: Cardinal Health Isolation Gown, Cardinal Health200, LLC (2016) Summary page 4.

## Most influential descendants
- K210785: Disposable Surgical Gowns (2021), 3 descendants of its own
- K223467: Disposable Isolation Gown (2023), 0 descendants of its own
- K223304: Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (2023), 0 descendants of its own
- K223411: Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (2023), 0 descendants of its own
- K212633: Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue (2021), 0 descendants of its own

## Indications for use
Wildcat PE Surgical Isolation Gown Full Back is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Wildcat PE Surgical Isolation Gown Full Back meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Wildcat PE Surgical Isolation Gown Full Back is a single use, disposable medical device provided non-sterile.

Source page: https://510kreport.com/device/K202310
Methodology: https://510kreport.com/methodology