Product code QDO

Device name

Fentanyl And Other Opioid Protection Glove

Medical specialty

General Hospital

Device class

1

Regulation number

880.6250

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset