QDO · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6250
Classification
FDA Product Code
QDO
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 880.6250
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.