Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K042028
    Device Name
    VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE
    Date Cleared
    2004-08-09

    (12 days)

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

    **ZIBO BORUI PLASTIC **& RUBBER PRODUCTS CO

    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 hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
    Device Description
    Powder Free Vinyl Examination Gloves
    Ask a Question

    Ask a specific question about this device

    K Number
    K040828
    Device Name
    DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES
    Date Cleared
    2004-04-19

    (19 days)

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

    **ZIBO BORUI PLASTIC **& RUBBER PRODUCTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powdered Vinyl Patient Examination Gloves
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1