# K974356: Surgeon's Gloves

- Pathway: 510(k) (Traditional)
- Applicant: American Health Products, Inc.
- Decided: Jan 29, 1998 after 71 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- 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 K832448 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832448: Triflex Surgeon's Gloves, Travenol Laboratories, S.A. (1984) Summary page 2.
- K903446: Comfit Surgeon's Gloves, Wembley Rubber Products (M) Sdn Bhd (1990) Summary page 2.

## Indications for use
The surgeon’s gloves are sterile gloves to be worn by surgeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.

Source page: https://510kreport.com/device/K974356
Methodology: https://510kreport.com/methodology