# K192635: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Jan 17, 2020 after 116 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.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133168: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Wrp Asia Pacific Sdn. Bhd. (2014) Summary page 4.

## Most influential descendants
- K220229: Powder Free Nitrile Examination Gloves, Orange (2022), 0 descendants of its own

## Indications for use
A patient examination glove is a 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/K192635
Methodology: https://510kreport.com/methodology