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510(k) Data Aggregation

    K Number
    K992031
    Device Name
    LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER SOLUBLE PROTEIN)
    Manufacturer
    SHANGHAI CHANGZHENG LATEX FACTORY
    Date Cleared
    1999-07-12

    (26 days)

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

    SHANGHAI CHANGZHENG LATEX FACTORY

    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 hand or finger to prevent contamination between patient and examiner.
    Device Description
    Latex Examination Glove Powder Free, With Protein Labeling Claim (50 Micrograms or Less Total Water Soluble Protein)
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