# K260806: Nitrile Disposable Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Vista Industries,, LLC
- Decided: Jun 3, 2026 after 83 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: 4 generations back to K171422 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240361: Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL), Hebei Titans Hongsen Medical Technology Co., Ltd. (2024) Summary page 5.

## Indications for use
Nitrile disposable examination gloves are non-sterile 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/K260806
Methodology: https://510kreport.com/methodology