# K081464: Sterile, Powder-Free, Latex Exam Gloves, Models 2D7018PF Series, 2D7028PF Series

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Aug 28, 2008 after 93 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 K024292 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024292: Modification to Positive Touch Powder-Free Latex Examination Gloves with Protein and Chemotherapy Labeling Claim, Allegiance Healthcare Corp. (2003) Summary page 1.

## Indications for use
A powder-free patient examination glove 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/K081464
Methodology: https://510kreport.com/methodology