LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K100162
    Device Name
    MULTIPLE PRIVATE LABEL
    Manufacturer
    BIOGREEN YIELDS SDN.BHD
    Date Cleared
    2010-03-24

    (63 days)

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

    BIOGREEN YIELDS SDN.BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's for the expected contamination between patient and examiner. This device is for over-the counter use. A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. This device is for over-the counter use.
    Device Description
    Non Sterile Powder Free Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-05, Standard Specification for Nitrile Examination Gloves for Medical Application.
    Ask a Question

    Page 1 of 1