# K103337: Multiple Name

- Pathway: 510(k) (Traditional)
- Applicant: Ideal Quality Sdn., Bhd.
- Decided: Feb 25, 2011 after 102 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
Longest line of descent: 1 generation back to K060771 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060771: Powder-Free Nitrile Patient Examination Glove,White (Non-Colored) and Blue Colored, Kossan Latex Industries (M)Sdn Bhd (2006) Summary page 1.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K103337
Methodology: https://510kreport.com/methodology