# K012166: Nitrile Powder-Free Medical Examination Glove (Brown)

- Pathway: 510(k) (Traditional)
- Applicant: Best Manufacturing Company
- Decided: Aug 1, 2001 after 21 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: 2 generations back to K902696 (1990). 3 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K992170: N-Dex Blue Powder-Free Nitrile Medical Examination Glove, Best Manufacturing Company (1999) Summary page 1.
- K915086: Hpi Brown Nitrile Sensi-Grip Surgical Gloves, Hpi, Inc. (1992) Summary page 1.

## Most influential descendants
- K030075: Nitrile Powder-Free Medical Examination Glove (Blue) (Textured and Non-Textured) (2003), 0 descendants of its own
- K022024: Nitrile Powder-Free Medical Examination Glove (Green) (2002), 0 descendants of its own

## Indications for use
The Nitrile Powder-Free Medical Examination Glove (brown) 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/K012166
Methodology: https://510kreport.com/methodology