inforMED
QDOClass I

Fentanyl And Other Opioid Protection Glove

General Hospital · 21 CFR 880.6250

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.

MDR events12All time
Recalls0All time
Registered firms440Currently listed
510(k) clearances0All time

Event type breakdown

Malfunction12

Recalls

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510(k) clearances

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No 510(k) clearances on file for this product code.