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510(k) Data Aggregation

    K Number
    K993912
    Device Name
    AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI
    Manufacturer
    LATEXX PARTNERS, INC.
    Date Cleared
    2000-02-09

    (84 days)

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

    LATEXX PARTNERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AMBIDERM Powder Free Latex Examination Gloves are intended for single use for medical purposes and are worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
    Device Description
    Ambiderm Powder Free Latex Examination Gloves with Protein Labeling Claim meet the current specifications listed under the ASTM specifications D 3578-99 standard specification for rubber examination gloves. They are Violet, Blue, Green or Pink colored.
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