# K032024: Powder-Free Nitrile Examination Gloves, Blue Color (Tested for  Use with Chemotherapy Drugs)

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei (Usa), Inc.
- Decided: Oct 29, 2003 after 121 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K101436: Pearlescent Powder Free Nitrile Examination Glove with Aloe Vera (Yellow, Red, Green, Black, Blue) (2010), 0 descendants of its own

## Indications for use
a disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier

Source page: https://510kreport.com/device/K032024
Methodology: https://510kreport.com/methodology