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510(k) Data Aggregation

    K Number
    K242645
    Device Name
    INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant
    Manufacturer
    Project Chemistry, Inc.
    Date Cleared
    2024-12-06

    (94 days)

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

    Project Chemistry, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INA Moisturizing Intimate Water-Based 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 compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
    Device Description
    INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is a non-sterile, water-based, personal lubricant that is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The device is for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication. INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is sold as an over-the-counter (OTC) product in a 3 fl. oz./ 90 mL Polyethylene vinyl alcohol bottle with Polypropylene flip cap. The Tube will be packaged in an outer box. This product is composed of Deionized Water, Organic Certified Aloe Vera Gel, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Propanediol, Sclerotium Gum, Sodium Hyaluronate, Tremella Fuciformis Sporocarp Extract, Xanthan Gum, Lactic Acid, Red Alga Gel EC, Sodium Benzoate, Potassium Sorbate, Moringa Oleifera Seed Oil, Cariborg Sea Buckthorn Oil Refined.
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