# K992170: N-Dex Blue Powder-Free Nitrile Medical Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Best Manufacturing Company
- Decided: Sep 7, 1999 after 71 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: 1 generation back to K902696 (1990). 1 ancestor in all.
8 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902696: N-DEX, Moss Point Glove Co. (1990) Summary page 1.

## Most influential descendants
- K012899: Green Nitrile Powder-Free Medical Exmaination Glove (2001), 4 descendants of its own
- K082125: N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free, Model# 7700PFT (2008), 2 descendants of its own
- K012166: Nitrile Powder-Free Medical Examination Glove (Brown) (2001), 2 descendants of its own
- 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 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/K992170
Methodology: https://510kreport.com/methodology