# K032374: Powder-Free Nitrile Patient Chemotherapy Examination Glove, Blue Colored

- Pathway: 510(k) (Traditional)
- Applicant: Perusahaan Getah Asas Sdn. Bhd.
- Decided: Oct 22, 2003 after 82 days
- Product code: LZC (Medical Glove, Specialty)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 4 (0 Class I)
- 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.

## Recalls of this device
- Aug 4, 2011 · Not classified · Z-3115-2011: Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
- Aug 4, 2011 · Not classified · Z-3117-2011: Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
- Aug 4, 2011 · Not classified · Z-3114-2011: Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
- Aug 4, 2011 · Not classified · Z-3116-2011: Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.

## Indications for use
A patient 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. Tested for use with Chemotherapy Drugs.

Source page: https://510kreport.com/device/K032374
Methodology: https://510kreport.com/methodology