# K971191: Far-East Shoe Covers

- Pathway: 510(k) (Traditional)
- Applicant: Far East Science & Technology Development Co., Ltd.
- Decided: Jul 10, 1997 after 101 days
- Product code: FXP (Cover, Shoe, Operating-Room)
- 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 Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.

Source page: https://510kreport.com/device/K971191
Methodology: https://510kreport.com/methodology