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510(k) Data Aggregation

    K Number
    K142726
    Device Name
    O Glide Personal Lubricant
    Manufacturer
    Grafenberg Labs
    Date Cleared
    2015-07-24

    (304 days)

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

    Grafenberg Labs

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    O Glide Personal Lubricant is a personal lubricant, 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 not compatible with condoms.
    Device Description
    The O Glide Personal Lubricant is a non-sterile, oil-based personal lubricant designed to supplement the body's own natural lubrication fluids and to enhance the ease and comfort of intimate sexual activity. The O Glide Personal Lubricant is specifically formulated with naturally occurring plant derived oils. The specifications for the subject lubricant include appearance, odor, viscosity, total microbial count (TAMC), total combined yeast and molds count, and absence of pathogenic organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Coliforms, and Clostridia). Osmolality, pH, and antimicrobial effectiveness are not applicable to the subject device because it is an oil-based lubricant. The product is bottled in an LDPE white plastic tube with a white flip top cap. The tube is packaged in a carton for sale to consumers.
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