# K952115: Barrier Gown, Kool-Gard Backless Gown

- Pathway: 510(k) (Traditional)
- Applicant: American Threshold Industries, Inc.
- Decided: Sep 25, 1995 after 143 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K182830: Cardinal HealthTM Poly-Coated Open-Back Protective Gown (2019), 1 descendant of its own
- K212464: Dukal Corporation AAMI Level 4 Open-Back Protective Gown (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K952115
Methodology: https://510kreport.com/methodology