# K152479: HG Pro Nitrile Powder Free Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Healthy Glove Co., Ltd.
- Decided: Apr 4, 2016 after 217 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
Longest line of descent: 1 generation back to K022548 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022548: Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves, Latexx Manufacturing Sdn.Bhd. (2002) Summary page 4.

## Indications for use
A patient examination glove 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/K152479
Methodology: https://510kreport.com/methodology