# K123469: Powder Free Nitrile Patient Examination Glove, Blue and White Colored, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Wear Safe (Malaysia) Sdn Bhd - Facility II
- Decided: Feb 19, 2013 after 98 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 K062764 (2007). 3 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093500: Powder Free Nitrile Examination Gloves, White (Non-Colored) or Blue (Colored), Non-Sterile, Wear Safe (Malaysia) Sdn. Bhd. (2010) Summary page 1.
- K111772: Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored). Non-Sterile, Kossan Latex Industries (M)Sdn Bhd (2011) Summary page 1.

## Most influential descendants
- K142862: POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). (2015), 8 descendants of its own
- K172015: Powder Free Nitrile Examination Gloves, Blue (Colored) (2017), 5 descendants of its own
- K220442: Synguard Nitrile Exam Glove (2022), 2 descendants of its own
- K201857: Powder Free Nitrile Examination Glove Black and Dual Color White-Blue (2021), 1 descendant of its own
- K253160: Syntex Exam Gloves (2026), 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 to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K123469
Methodology: https://510kreport.com/methodology