# K172015: Powder Free Nitrile Examination Gloves, Blue (Colored)

- Pathway: 510(k) (Traditional)
- Applicant: Careglove Global Sdn. Bhd.
- Decided: Sep 26, 2017 after 85 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: 4 generations back to K062764 (2007). 5 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142862: POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored)., Careplus (M) Sdn Bhd (2015) Summary page 4.

## Most influential descendants
- K220442: Synguard Nitrile Exam Glove (2022), 2 descendants of its own
- K253160: Syntex Exam Gloves (2026), 0 descendants of its own
- K232576: Medical Nitrile Examination Gloves (2023), 0 descendants of its own
- K212014: Medical Nitrile Examination Gloves (2021), 0 descendants of its own
- K211540: Edma Synthetic Nitrile Examination Gloves (2021), 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/K172015
Methodology: https://510kreport.com/methodology