LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K972838
    Device Name
    POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED)
    Manufacturer
    ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD.
    Date Cleared
    1997-08-15

    (14 days)

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

    ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    As a medical glove, worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Powder-Free, Poly-Coated Nitrile Examination Glove, Purple or White (noncolored)
    Ask a Question

    Ask a specific question about this device

    K Number
    K972177
    Device Name
    POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
    Manufacturer
    ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD.
    Date Cleared
    1997-07-29

    (49 days)

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

    ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    As a medical glove, wom on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Powdered Nitrile Examination Glove, Blue or White (non-colored)
    Ask a Question

    Ask a specific question about this device

    K Number
    K972195
    Device Name
    POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
    Manufacturer
    ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD.
    Date Cleared
    1997-07-29

    (48 days)

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

    ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    As a medical glove, worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Powder-Free Nitrile Examination Glove, Blue or White (non-colored)
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1