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510(k) Data Aggregation

    K Number
    K152646
    Device Name
    SYLK PERSONAL LUBRICANT
    Date Cleared
    2016-03-11

    (177 days)

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

    TORO MANAGEMENT LLC DBA SYLK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sylk Personal Lubricant is intended for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms and polyurethane condoms. Sylk Personal Lubricant is intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.
    Device Description
    Sylk Personal Lubricant is formulated to be a non-sterile, non-greasy, non-sticky, non-staining, viscous liquid. The device is not a contraceptive and does not contain a spermicide. This device is packaged in 3 ounce tubes. The specifications for the Sylk Personal Lubricant include appearance, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total microbial count, total yeast and mold count, and absence of pathogenic organisms.
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