# K082428: N-Dex BWC Pink Nitrile Medical Examination Glove, Non Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Best Glove, Inc.
- Decided: Feb 10, 2009 after 172 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 K001375 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001375: Ultimate N-Dex Power Free Nitrile Exmination Glove (Tested for Use with Chemotherapy Drugs), Best Manufacturing Company (2000)

## Indications for use
The N-DEX® BWC TM Pink 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) This device has been tested for use with specific chemotherapy drugs. This device is not intended to be used as a chemical barrier.

Source page: https://510kreport.com/device/K082428
Methodology: https://510kreport.com/methodology