# K033086: Neosoothe Polymer Coated Powder-Free Polychloroprene Patient Examination Gloves with Aloe

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Medisafe Technologies
- Decided: Feb 26, 2004 after 150 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 examination glove made of synthetic rubber intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner.

Source page: https://510kreport.com/device/K033086
Methodology: https://510kreport.com/methodology