# K952116: Cover Gown

- Pathway: 510(k) (Traditional)
- Applicant: American Threshold Industries, Inc.
- Decided: Sep 5, 1995 after 123 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
No predicates in its family tree.
17 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K160339: Cardinal Health Isolation Gown (2016), 16 descendants of its own
- K190306: AMD Ritmed AssureWear VersaGown (2020), 6 descendants of its own
- K202310: Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back (2021), 5 descendants of its own
- K210785: Disposable Surgical Gowns (2021), 3 descendants of its own
- K203415: Surgical Isolation Gown (2021), 1 descendant of its own

Source page: https://510kreport.com/device/K952116
Methodology: https://510kreport.com/methodology