# K153562: Powder Free Blue Nitrile Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Vietglove Corporation
- Decided: Apr 1, 2016 after 109 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.
7 later devices descend from it; 3 cite it directly.
0 of 8 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
- K210369: Powder Free Nitrile Examination Glove (2021), 2 descendants of its own
- K201428: Powder Free Black Nitrile Examination Glove (2021), 1 descendant of its own
- K210375: Powder Free Blue Nitrile Examination Glove (2021), 1 descendant of its own
- K221378: Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile (2022), 0 descendants of its own
- K212751: Powder Free Nitrile Examination Glove (2022), 0 descendants of its own

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner

Source page: https://510kreport.com/device/K153562
Methodology: https://510kreport.com/methodology