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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fentanyl and other opioid protection glove
Regulation Description Non-powdered patient examination glove.
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.
Product CodeQDO
Regulation Number 880.6250
Device Class 1

MDR Year MDR Reports MDR Events
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 11 11
Contamination 10 10
Product Quality Problem 9 9
Manufacturing, Packaging or Shipping Problem 8 8
Fail-Safe Problem 8 8
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 8 8
No Clinical Signs, Symptoms or Conditions 4 4

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