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510(k) Data Aggregation

    K Number
    K982114
    Device Name
    LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES
    Date Cleared
    1999-01-21

    (219 days)

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

    M/S MIDLAND LATEX PRODUCTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    LOPRP, AVT, EXAM-PERFECT, GUARDIAN, MILLENIUM FUS S2 & HEALTH TEC - Powder Free Latex Examination Glove with Protein Content Labeling Claim (50 micrograms or less)
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