# K993325: Innovative Gloves, Nitrile Butadiene Rubber Powder-Free

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Gloves Co;, Ltd.
- Decided: Nov 5, 1999 after 32 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K083908: Black Nitrile Examination Gloves (2009), 0 descendants of its own

## Indications for use
A Madical glove is worn on the hand of heaith care and similar personnel to prevent contamination between health caere personnel and patient.

Source page: https://510kreport.com/device/K993325
Methodology: https://510kreport.com/methodology