# K050152: Palm Pro Premium, Model 6PF1 & Palm Pro, Model 6PF2, Latex Exam Glove

- Pathway: 510(k) (Traditional)
- Applicant: Dipped Products (Thailand), Ltd.
- Decided: Feb 7, 2005 after 14 days
- Product code: LYY (Latex 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 K913766 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012815: Safeskin Healthtouch Powder-Free Exam Glove with Vitamin E and Aloe, Kimberly-Clark Corp. (2001) Summary page 1.
- K913766: Ansell NO Powder Ambi Patient Examination Gloves, Ansell, Inc. (1993) Summary page 1.

## Indications for use
A powder-free patient examination glove is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K050152
Methodology: https://510kreport.com/methodology