LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K183050
    Device Name
    GLISSANT Intimate Lubricant
    Manufacturer
    Vjuvenate, LLC
    Date Cleared
    2019-07-08

    (248 days)

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

    Vjuvenate, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GLISSANT Intimate Lubricant Fragrance Free/Sea Salt & Caramel is a personal lubricant, for penile and/or vaginal application, intended to moisturize and 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, polyisoprene, and polyurethane condoms.
    Device Description
    GLISSANT Intimate Lubricant is a water-based, non-sterile, colorless, viscous personal lubricant It does not contain a contraceptive or spermicidal component. The device is packaged in a polyethylene bottle with a lockdown pump. The primary packaging is plastic placed inside of a display box (dimensions 1.375" width x 1.375" depth x 4.75" height).
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1