# K100895: Palm-Pro 0.30MM Powder Free Latex Examinaion Gloves (6PF2G30)

- Pathway: 510(k) (Traditional)
- Applicant: Dipped Products Limited
- Decided: May 27, 2011 after 422 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 K935315 (1994). 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)
- K022808: Dermagrip Powder Free Latex Examination Gloves, Non-Sterile with Protein Content Labeling Claim (50 UG or Less), Wrp Specialty Products Sdn. Bhd. (2002) Summary page 1.
- K935315: Maytex Powder-Free Latex Examination Gloves, Maytex Corp. (1994) Summary page 1.

## Indications for use
Palm Pro X - Powder Free Latex Examination Gloves (6PF2G30) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K100895
Methodology: https://510kreport.com/methodology