# K082125: N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free, Model# 7700PFT

- Pathway: 510(k) (Traditional)
- Applicant: Best Glove, Inc.
- Decided: Nov 21, 2008 after 115 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: 3 generations back to K902696 (1990). 3 ancestors in all.
2 later devices descend 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)
- K012899: Green Nitrile Powder-Free Medical Exmaination Glove, Best Manufacturing Company (2001) Summary page 1.

## Most influential descendants
- K190159: Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile glove (2019), 1 descendant of its own
- K252075: Program insite® Powder-Free, Disposable Nitrile Exam Gloves (2025), 0 descendants of its own

## Indications for use
The N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).

Source page: https://510kreport.com/device/K082125
Methodology: https://510kreport.com/methodology