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510(k) Data Aggregation

    K Number
    K150973
    Device Name
    NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs
    Manufacturer
    TERANG NUSA SND BHD
    Date Cleared
    2015-08-04

    (113 days)

    Product Code
    KGOLZC
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    TERANG NUSA SND BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This Surgeons glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves are tested for use with Chemotherapy Drugs. Testing based on ASTM D6978-05
    Device Description
    Surgeons glove is a device made of synthetic rubber
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