Fentanyl And Other Opioid Protection Glove
The Fentanyl And Other Opioid Protection Glove is a disposable patient examination glove intended for medical purposes to prevent contamination between patient and examiner, with specific testing per ASTM D6978-05 for resistance to permeation by chemotherapy drugs, fentanyl citrate, and possibly other opioids. It is classified as FDA Class 1, subject to general controls only with no premarket notification required, under regulation 880.6250 in the General Hospital specialty. The product code is QDO. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QDO
- Device Class
- FDA class 1
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 162 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 162 registration numbers. Click on an entry to view related FDA registrations.