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510(k) Data Aggregation

    K Number
    K993820
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS
    Manufacturer
    FELDA RUBBER CORP.
    Date Cleared
    1999-12-02

    (20 days)

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

    FELDA RUBBER CORP.

    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
    Powder Free Latex Examination Gloves
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