# K971917: Kentron's Isolation Gown

- Pathway: 510(k) (Traditional)
- Applicant: Kentron Health Care, Inc.
- Decided: Sep 19, 1997 after 119 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
This device is intended to be worn to protect both the patient and healthcare personnel from transfer of micro-organisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K971917
Methodology: https://510kreport.com/methodology