# K140890: Nitrile Powder Free Examination Gloves (White/Dawn Blue/Dark Violet Blue (Dvbu)/Cobalt Blue (Cblu)

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Jul 24, 2014 after 107 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Nitrile Powder Free Examination Glove - Cobalt Blue (CBLU) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner The Nitrile Powder Free Examination Glove - Dark Violet Blue (DVBU) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner The Nitrile Powder Free Examination Glove - Dawn Blue is a non-sterile disposable device intended for Medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner The Nitrile Powder Free Examination Glove - White is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner

Source page: https://510kreport.com/device/K140890
Methodology: https://510kreport.com/methodology