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510(k) Data Aggregation

    K Number
    K232040
    Device Name
    Gynatrof
    Date Cleared
    2024-03-01

    (235 days)

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

    Tyros Biopharma Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Gynatrof 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. Gynatrof is compatible with natural rubber latex, polyisoprene condoms and polyurethane condoms.
    Device Description
    Gynatrof® is a personal lubricant intended to moisturize, lubricate, and enhance the ease and comfort of intimate sexual activity as well as supplement the body's natural lubrication. The product is supplied with a reusable, non-sterile, single-patient use applicator. Gynatrot® is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The product is intended for over-the-counter use. The device formulation consists of Aqua/Water, Hydroxyethylcellulose, Lactic Acid, Polysorbate 20, Potassium Sorbate, Sodium Hyaluronate, Sodium Levulinate, Tocopherol. Gynatrof® is supplied in a 50 mL white tube; each tube contains sufficient product for 20 applications using the reusable applicator.
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