# K130667: Powderfree Latex Examination Gloves Coated with Allogel

- Pathway: 510(k) (Traditional)
- Applicant: Preventive Care, Inc.
- Decided: Jul 24, 2013 after 134 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 K110102 (2011). 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)
- K110102: Powderfree Nitrile Examination Gloves Coated with Allogel,Colors Blue,Magneta,Copper and Without Allogel,Colors Blue,Mag, Preventive Care, Inc. (2011) Summary page 1.

## Indications for use
An Examination glove Is a disposable device Intended for medical purposes that Is worn on the examiners hand or finger, to prevent contamination between the patient and examiner.

Source page: https://510kreport.com/device/K130667
Methodology: https://510kreport.com/methodology