# K963809: Cool-Zone

- Pathway: 510(k) (Traditional)
- Applicant: Kappler USA
- Decided: Nov 20, 1996 after 58 days
- Product code: FYA (Gown, 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: 1 generation back to K932694 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932694: Kappler Pro/Vent Procedure Gown, Kappler, Inc. (1994) Summary page 1.

## Indications for use
The TE Gown is intended to provide the wearer an increased level of blood and other body fluid protection during certain surgical procedures that result in excessive blood exposures by providing total encapsulation.

Source page: https://510kreport.com/device/K963809
Methodology: https://510kreport.com/methodology