Fentanyl And Other Opioid Protection Glove

Device Code: 2792

Product Code(s): QDO

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 Chemothera

Device Classification Information

Device Type ID2792
Device NameFentanyl And Other Opioid Protection Glove
Physical StatePolymer Examination Medical Glove
Technical MethodDevice Is Worn On The Hand
Target AreaSkin Of The Hand
Regulation DescriptionNon-powdered Patient Examination Glove.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Submission Type510(k)
CFR Regulation Number880.6250 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeQDO
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2792
DeviceFentanyl And Other Opioid Protection Glove
Product CodeQDO
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNon-powdered Patient Examination Glove.
CFR Regulation Number880.6250 [🔎]
TPLC Last Update: 2019-04-02 20:18:52

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