# K083908: Black Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Gloves Co;, Ltd.
- Decided: Mar 6, 2009 after 66 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 K993325 (1999). 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)
- K993325: Innovative Gloves, Nitrile Butadiene Rubber Powder-Free, Innovative Gloves Co;, Ltd. (1999) Summary page 1.

## Indications for use
A powder free patient examination glove is a disposable device made of synthetic Nitrile butadiene rubber later material may bear a trace of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious material and other contaminants.

Source page: https://510kreport.com/device/K083908
Methodology: https://510kreport.com/methodology