# K172642: Orange Non Sterile Powder Free Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Central Medicare Sdn Bhd
- Decided: Nov 28, 2017 after 88 days
- Product code: LZC (Medical Glove, Specialty)
- 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 K143247 (2015). 1 ancestor in all.
12 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)
- K143247: Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored), Central Medicare Sdn Bhd (2015) Summary page 4.

## Most influential descendants
- K190942: Disposable Powder Free Nitrile Examination Glove, Pink/Black Color (2020), 10 descendants of its own
- K210463: Thermoplastic Elastomer (TPE) Hybrid Examination Glove (2022), 1 descendant of its own
- K233740: Black Nitrile Powder Free Patient Examination Glove, Non Sterile (2024), 0 descendants of its own
- K222103: Nitrile Patient Examination Gloves, Powder Free, Pink Color (2023), 0 descendants of its own
- K222531: Synthetic Polymer Glove - Polyethylene (Black) (2023), 0 descendants of its own

## Indications for use
Orange Non Sterile Powder Free Nitrile Examination Gloves 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/K172642
Methodology: https://510kreport.com/methodology