# K040607: Modification to Powderfree Colored and Flavored Chloroprene Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Medisafe Technologies
- Decided: Apr 22, 2004 after 45 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
A patient examination glove made of synthetic rubber is a disposable medical device intended for medical purposes worn on the examoiners hands or fingers to prevent possible contamination between patient and examiner.(Tested for Chemo Use

Source page: https://510kreport.com/device/K040607
Methodology: https://510kreport.com/methodology