# K120066: Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored. Non-Sterile, Low Dermatitis Potential

- Pathway: 510(k) (Traditional)
- Applicant: Kossan Latex Industries (M)Sdn Bhd
- Decided: Nov 16, 2012 after 312 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 K102790 (2010). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102790: Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Deramatitis Potential and Chemotherapy Drug, Perusahaan Getah Asas Sdn. Bhd. (2010) Summary page 1.

## Most influential descendants
- K123749: Powder Free Nitrile Patient Examination Gloves, Green, Non-Sterile (2013), 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 examinee's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K120066
Methodology: https://510kreport.com/methodology