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510(k) Data Aggregation

    K Number
    K040448
    Device Name
    GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM
    Manufacturer
    ROSNER-MAUTBY MEDITRADE(THAILAND) LTD.
    Date Cleared
    2004-03-23

    (32 days)

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

    ROSNER-MAUTBY MEDITRADE(THAILAND) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between the patient and the examiner.
    Device Description
    Gentle Skin and (multiple labels) Powder Free, Polyment Coated Glove (With Protein Label Claim)/ 50 ml
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