QDO

Fentanyl And Other Opioid Protection Glove

Product code

QDO

Device name

Fentanyl And Other Opioid Protection Glove

Device class

Class 1

21 CFR

21 CFR 880.6250

Medical specialty

General Hospital

Marketing pathway

510(K)

FDA classification definition

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Fentanyl and other opioid protection gloves are tested for use with chemotherapy drugs, Fentanyl Citrate, and possibly other opioids per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Definition text from the FDA device classification database (U.S. federal government work, public domain).