# K081315: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (Pink, Black, Grey, and Blue Pepperment)

- Pathway: 510(k) (Traditional)
- Applicant: Gx Corporation Sdn Bhd
- Decided: Aug 11, 2008 after 94 days
- Product code: LZA (Polymer 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
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.

Source page: https://510kreport.com/device/K081315
Methodology: https://510kreport.com/methodology