# K960407: Comfit Orthopedic

- Pathway: 510(k) (Traditional)
- Applicant: Wembley Rubber Products (M) Sdn Bhd
- Decided: Apr 26, 1996 after 88 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
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
The gloves are intended to be wom on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient’s body, fiuids, waste, or environment.

Source page: https://510kreport.com/device/K960407
Methodology: https://510kreport.com/methodology