# K121594: Colored Powder Free Latex Examination Glove (White and Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Tekmedic (M) Sdn Bhd
- Decided: Oct 25, 2012 after 147 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A powder-free latex examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs and their breakthrough detection time are as follows

Source page: https://510kreport.com/device/K121594
Methodology: https://510kreport.com/methodology