# K111464: Palm-Pro Powder Free Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Dipped Products (Thailand), Ltd.
- Decided: Apr 19, 2012 after 329 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: 3 generations back to K013016 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081569: Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with Chemotherapy Drugs, Dynarex Corporation (2008) Summary page 1.

## Indications for use
The Palm-Pro Powder Free Nitrile Examination Glove is "a 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/K111464
Methodology: https://510kreport.com/methodology