# K953590: Comfit

- Pathway: 510(k) (Traditional)
- Applicant: Wembley Rubber Products (M) Sdn Bhd
- Decided: Jun 27, 1996 after 332 days
- Product code: LYY (Latex Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- 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 its predicate without a number.
- (no number) Class I latex patient examination glove 80 LYY, powder free, hypoallergenic, protein labeling content: named in the summary without a submission number

## 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/K953590
Methodology: https://510kreport.com/methodology