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510(k) Data Aggregation

    K Number
    K111133
    Device Name
    NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)
    Manufacturer
    SSC SURAT THANI
    Date Cleared
    2011-06-24

    (63 days)

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

    SSC SURAT THANI

    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.
    Device Description
    Non-Sterile, powder-free latex examination gloves with protein claim (50 micrograms or less).
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