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510(k) Data Aggregation

    K Number
    K011995
    Device Name
    POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    QUALITY LATEX PRODUCTS MALAYSIA SDN BHD
    Date Cleared
    2001-07-31

    (35 days)

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

    QUALITY LATEX PRODUCTS MALAYSIA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purpose and A patient Exammation grovent contamination between health care personnel and the patient.
    Device Description
    Polymer Coated Powder free latex examination gloves (with a protein label claim 50 MICKOGRAMS OR LESS
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