Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K212260
    Device Name
    Sensuva Premium Silicone Personal Lubricant
    Manufacturer
    Valencia Naturals, Inc
    Date Cleared
    2022-04-13

    (267 days)

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

    Valencia Naturals, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sensuva Premium Silicone Personal Lubricant is a silicone-based personal lubricant for penile, anal 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, polyisoprene and polyurethane condoms.
    Device Description
    Sensuva Premium Silicone Personal Lubricant is a non-sterile, clear, colorless, thin liquid, silicone-based personal lubricant. This device is for penile, anal, 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. It is compatible with natural rubber latex, polyisoprene and polyurethane condoms. Its formulation consists of dimethicone, dimethiconol, and cyclopentasiloxane. Sensuva Premium Silicone Personal Lubricant is sold as an over-the-counter (OTC) device and is provided in polyethylene terephthalate bottles. The 1.93 fl. oz./57 mL bottles are fitted with 20/410 smooth black pump sprayers and clear polypropylene caps. The 4.23 fl. oz./125 mL and 8.12 fl. oz./240 mL bottles are capped with 24/410 smooth black lotion pumps.
    Ask a Question

    Page 1 of 1