# K991615: Polyurethane Powder Free Dental Examination Glove, Polyurethane Powder Free Medical Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Maxxim Medical
- Decided: Jul 30, 1999 after 81 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 K944182 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965095: Nitra-Touch Powder-Free Nitrile Medical Examination Glove, Ansell Edmont Industrial, Inc. (1997) Summary page 1.
- K944182: Powder Free Medical Glove, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.

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

## Indications for use
A patient examination glove is a dispoéable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K991615
Methodology: https://510kreport.com/methodology