# K171541: Powder Free Nitrile Examination Gloves (Orange)

- Pathway: 510(k) (Traditional)
- Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
- Decided: Sep 20, 2017 after 117 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: 2 generations back to K022904 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140418: Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Wrp Rubber Products Sdn Bhd (2014) Summary page 4.

## Indications for use
The Powder Free Nitrile Examination Gloves (Orange) is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between examiner and patient.

Source page: https://510kreport.com/device/K171541
Methodology: https://510kreport.com/methodology