# K041913: Powderfree Colored and Flavored Chloreprene Patient Examination Gloves Tested for Chemo Use

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Medisafe Technologies
- Decided: Dec 1, 2004 after 139 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
The device is a disposable patient examination glove made of synthetic rubber intended for medical purposes. It is donned by the examiner on the hands to prevent possible contamination between patient and examiner (Tested for Chemo use).

Source page: https://510kreport.com/device/K041913
Methodology: https://510kreport.com/methodology