# K140610: Nitrile Powder Free Examination Glove - Aqua Blue (Ablu) / Violet Blue (Vblu) / Dark Blue (Dkbu)

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Jun 20, 2014 after 102 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. The FDA summary names no predicate by number.

## Indications for use
The Nitrile Powder Free Examination Gloves - Violet Blue (VBLU) is a non-sterile disposable device intended for medical and dental purpose that is worn on the examinee's hand to prevent contamination between patient and examiner. The Nitrile Powder Free Examination Gloves - Dark Blue (DKBU) is a non-sterile disposable device intended for medical and dental purpose that is worn on the examinee's hand to prevent contamination between patient and examiner. The Nitrile Powder Free Examination Gloves - Aqua Blue (ABLU) is a non-sterile disposable device intended for medical and dental purpose that is worn on the examinee's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K140610
Methodology: https://510kreport.com/methodology