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510(k) Data Aggregation

    K Number
    K970577
    Device Name
    GLYDE DAM LOLLYES
    Manufacturer
    GLYDE USA, INC.
    Date Cleared
    1998-01-08

    (328 days)

    Product Code
    MSC
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLYDE USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Glyde Dam Lollyes Mare a thin 10" x 6" natural rubber latex sheet specially designed as a barrier for use while performing cunnilingus (oral/vaginal sex) ONLY, and are not intended for use during oral/anal sex. Glyde Dam Lollyes™, when properly used, may help reduce the risk of catching or spreading many sexually transmitted diseases ("STDs") such as syphilis, gonorrhea, chlamydia infections, genital herpes and AIDS. However, they cannot eliminate the risk. During intimate contact, lesions and various bodily fluids can transmit STDs. Therefore, the Glyde Dam Lollyes™ should be applied each and every time before any such contact occurs. WARNING: DO NOT USE DURING PENETRATING PENILE/VAGINAL OR PENILE/ANAL INTERCOURSE. WARNING: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS IN SOME INDIVIDUALS. IF YOU EXPERIENCE A REACTION. STOP USING THIS PRODUCT AND CONTACT YOUR PHYSICIAN.
    Device Description
    Glyde Dam Lollyes are manufactured from good quality rubber latex conforming to ASTM 1076-88. The size of each Glyde Dam Lollyes is 10.0 inches (± 0.1 inch) by 6.0 inches (± 0.1 inch) by 0.08 millimeters thick (± 0.0006 millimeters.) Glyde Dam Lollyes are designed to be used while performing cunnilingus. Qualification testing (biocompatibility, tensile strength/elongation, and virus) has been performed to satisfactorily conclude that Glyde Dam Lollyes operate as intended, when used properly. Finally, Glyde Dam Lollyes are tested for a smooth surface (i.e.: the presence of cracks and blisters,) and are visually tested for holes, tears, foreign materials and the like, during the manufacturing process of each lot.
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