# K190159: Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile glove

- Pathway: 510(k) (Traditional)
- Applicant: Showa Best Glove, Inc.
- Decided: May 6, 2019 after 96 days
- Product code: LZC (Medical Glove, Specialty)
- 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 K902696 (1990). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082125: N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free, Model# 7700PFT, Best Glove, Inc. (2008) Summary page 4.

## Most influential descendants
- K252075: Program insite® Powder-Free, Disposable Nitrile Exam Gloves (2025), 0 descendants of its own

## Indications for use
The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or fingers to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K190159
Methodology: https://510kreport.com/methodology