# K970988: Far-East Bouffant Caps

- Pathway: 510(k) (Traditional)
- Applicant: Far East Science & Technology Development Co., Ltd.
- Decided: Jul 10, 1997 after 114 days
- Product code: LYU (Accessory, Surgical Apparel)
- Device class: 1
- 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 Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect both surgical patient and operating room personnel from transfer of micro-organisms and particulate materials.

Source page: https://510kreport.com/device/K970988
Methodology: https://510kreport.com/methodology