# K063046: Nitrile Powder Free Examination Gloves (Green)

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega Sdn Bhd
- Decided: Nov 17, 2006 after 44 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K072145: Medical Glove Series (2008), 1 descendant of its own
- K150612: Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free) (2015), 0 descendants of its own

## Indications for use
The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K063046
Methodology: https://510kreport.com/methodology