# K143247: Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)

- Pathway: 510(k) (Traditional)
- Applicant: Central Medicare Sdn Bhd
- Decided: Jan 22, 2015 after 71 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
No predicates in its family tree.
13 later devices descend from it; 1 cites 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K172642: Orange Non Sterile Powder Free Nitrile Examination Gloves (2017), 12 descendants of its own
- 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

Source page: https://510kreport.com/device/K143247
Methodology: https://510kreport.com/methodology