# K960416: Comfit Microptic

- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K021119: Powdered Brown Latex Surgical Gloves, Sterile with Expiration Date Labeling Claim & Protein Content Labeling Claim (2002), 0 descendants of its own

## Indications for use
The gloves are intended to be worn 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, fluids, waste, or environment.

Source page: https://510kreport.com/device/K960416
Methodology: https://510kreport.com/methodology