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510(k) Data Aggregation

    K Number
    K000913
    Device Name
    POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    Date Cleared
    2000-08-10

    (141 days)

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

    HANDSAFE PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K960386
    Device Name
    HANDSAFE
    Date Cleared
    1996-06-21

    (147 days)

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

    HANDSAFE PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

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