510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QDOClass I

Fentanyl And Other Opioid Protection Glove

21 CFR 880.6250 / General Hospital
FDA source (opens on fda.gov)

QDO is the FDA product code for Fentanyl And Other Opioid Protection Glove, a class I device type, regulated under 21 CFR 880.6250. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QDO
Device name
Fentanyl And Other Opioid Protection Glove
FDA 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.
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 160 companies shown, in name order