# K101917: Comfort Rubber Gloves Ind.SDN.BHD.

- Pathway: 510(k) (Traditional)
- Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
- Decided: Oct 29, 2010 after 112 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 no predicate by number.

## Indications for use
A powder-free patient examination glove is a disposable device made of natural rubber latex material that is intended for medical purposes to be worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K101917
Methodology: https://510kreport.com/methodology