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510(k) Data Aggregation

    K Number
    K051333
    Device Name
    NITRILE EXAMINATION GLOVES, POWDER FREE
    Date Cleared
    2005-07-22

    (60 days)

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

    SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is disposable and intended for medical purposes to be worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Nitrile Examination Gloves, Powder Free
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    K Number
    K982416
    Device Name
    SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE
    Date Cleared
    1998-11-24

    (134 days)

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

    SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand(s) of health care and similar personnel To prevent contamination between heatlh care personnel and the patient.
    Device Description
    LATEX EXAMINATION GLOVE, POWDER-FREE
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