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    K Number
    K974356
    Device Name
    SURGEON'S GLOVES
    Manufacturer
    AMERICAN HEALTH PRODUCTS, INC.
    Date Cleared
    1998-01-29

    (71 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN HEALTH PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The surgeon's gloves are sterile gloves worn by surgeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.
    Device Description
    Surgeon's Gloves or Surgical Gloves. Anatomical in shape. Hand Specific (Left or Right). Available in sizes 6, 6½, 7, 7½, 8, 8½, 9. Made from Natural Rubber Latex, Sulphur, Zinc Oxide, ZDEC, ZDBC, Titanium Dioxide, Antioxidant (Styrenated Phenol), and Absorbable Corn Starch. Designed to comply with the physical measurements of ASTM D 3577.
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