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510(k) Data Aggregation
K Number
K232252Device Name
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)
Manufacturer
Date Cleared
2023-11-28
(123 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Dehai (Shandong) Medical Gloves, Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) are made from synthetic rubber latex. It is single use and powder-free. The subject device is a patient examination glove made from nitrile latex compound, Black and Orange color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. The available sizes are Small, Medium, Large ,X-Large and XX-Large.
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