Product Classification

• 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.
• Physical State: Polymer examination medical glove
• Technical Method: Device is worn on the hand
• Target Area: Skin of the hand
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: QDO
• Premarket Review: Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B); Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 880.6250
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 6-496 ASTM F739-20
  Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact

Third Party Review

Not Third Party Eligible