# K110960: Royal Imperial Nitrile Examination Gloves Textured Powder-Free

- Pathway: 510(k) (Traditional)
- Applicant: Koon Seng Sdn Bhd
- Decided: Jul 14, 2011 after 100 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 K090828 (2009). 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)
- K090828: Non-Sterile, Powder Free Nitrile Examination Gloves, Ultrawin Sdn Bhd (2009) Summary page 1.

## Indications for use
The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue is a single-use disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination. between patient and examiner.

Source page: https://510kreport.com/device/K110960
Methodology: https://510kreport.com/methodology