# K030207: Nitrile Powder-Free Examination Gloves, Problue, #7235 7 #7735

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Motex Healthcare Co., Ltd.
- Decided: May 2, 2003 after 101 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
- K041276: Powder-Free Nitrile Examination Gloves (2004), 0 descendants of its own

## Indications for use
Nitrile Powder-free Examination Glove, ProBlue is a disposable device made of synthetic materials intended for medical purposes that are worn on the examiner's hand or finger(s) to prevent contamination of potentially infectious materials between patient and examiner.

Source page: https://510kreport.com/device/K030207
Methodology: https://510kreport.com/methodology