# K971702: Far-East Barrier Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Far East Science & Technology Development Co., Ltd.
- Decided: Jul 8, 1997 after 61 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Far-East Barrier Gowns are disposable and single use devices, intended for general medical purposes, that are worn on to protect the isolation patients, medical staffs and visitors from transfer of micro-organisms, body fluids and particulate material during the general medical procedures and patient room visits in hospitals. These devices are non-sterile, not intended to be used by O. R. personnel for surgical procedures.

Source page: https://510kreport.com/device/K971702
Methodology: https://510kreport.com/methodology