# K260860: Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)

- Pathway: 510(k) (Traditional)
- Applicant: Basic Medical Technology, Inc.
- Decided: Apr 7, 2026 after 22 days
- Product code: LYZ (Vinyl 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: 2 generations back to K170575 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220992: Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple, Ever Global (Vietnam) Enterprise Corporation (2022) Summary page 5.

## Indications for use
The 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/K260860
Methodology: https://510kreport.com/methodology