# K201857: Powder Free Nitrile Examination Glove Black and Dual Color White-Blue

- Pathway: 510(k) (Traditional)
- Applicant: Careplus (M) Sdn Bhd
- Decided: Aug 20, 2021 after 410 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). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142858: POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored), Careplus (M) Sdn Bhd (2015) Summary page 4.
- K142862: POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored)., Careplus (M) Sdn Bhd (2015) Summary page 4.

## Most influential descendants
- K232550: Nitrile Examination Gloves, Dual Color Black-Blue (2023), 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/K201857
Methodology: https://510kreport.com/methodology