# K965095: Nitra-Touch Powder-Free Nitrile Medical Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Edmont Industrial, Inc.
- Decided: Apr 22, 1997 after 124 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K991615: Polyurethane Powder Free Dental Examination Glove, Polyurethane Powder Free Medical Examination Glove (1999), 1 descendant of its own
- K022095: Duraclean with Lycra Powder Free Polyurethane Medical Examination Glove (2002), 0 descendants of its own

## Indications for use
Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K965095
Methodology: https://510kreport.com/methodology