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510(k) Data Aggregation

    K Number
    K171276
    Device Name
    Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs
    Manufacturer
    TG Medical SDN. BHD.
    Date Cleared
    2017-08-21

    (112 days)

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

    TG Medical SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This powder free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating, nom personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with Chemotherapy Drugs in accordance ASTM D6978-05 (2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    This powder free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating, nom personnel to protect a surgical wound from contamination.
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