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510(k) Data Aggregation

    K Number
    K232064
    Device Name
    Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)
    Date Cleared
    2023-10-02

    (83 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Isikel Manufacturing LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentany) Citrate) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to permeation by Chemotherapy Drugs.
    Device Description
    Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) is a Powder Free Nitrile Examination Glove. The subject device is a patient examination glove manufactured 100% nitrile-Butadiene Copolymer dispersion), Per 21 CFR 880.6250, Product codes LZA, LZC, OPJ, QDO and Class 1, Blue Color, Powder Free and Non-Sterile. The device meets the specifications in ASTM D6319-19. Standard specifications for Nitrile Examination Gloves. The glove sizes provided are Small, Medium, Large, and X-Large. The gloves design features include ambidextrous and textured fingers. The subject device complies with requirements for standard practice for assessment of resistance of medical glove to permeation by chemotherapy drugs as per ASTM D6978-05 (2019).
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