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510(k) Data Aggregation

    K Number
    K182438
    Device Name
    Synthetic Polyisoprene Lubricated Male Condom - 5 senses
    Manufacturer
    Sxwell Usa LLC
    Date Cleared
    2018-12-06

    (90 days)

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

    Sxwell Usa LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synthetic Polyisoprene Lubricated Male Condom - 5 Senses is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).
    Device Description
    The Synthetic Polyisoprene Lubricated Male Condom – 5 Senses is a male contraceptive and prophylactic device made from synthetic rubber polyisoprene latex with a lubricant coating containing silicone gel with flavor and sensate. The subject condom is provided in a variety pack which includes three variants; Cooling, Tingling, and Warming. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190±10mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3-year shelf-life.
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    K Number
    K172473
    Device Name
    LifeStyles® SKYN® Intimate Moments Personal Lubricant
    Manufacturer
    SXWELL USA LLC
    Date Cleared
    2017-12-15

    (122 days)

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

    SXWELL USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LifeStyles® SKYN® Intimate Moments 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 polyisoprene condoms. This product is not compatible with natural rubber latex or polyurethane condoms.
    Device Description
    LifeStyles® SKYN® Intimate Moments Personal Lubricant is a non-sterile, propylene glycol/water/silicone-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. It is made of propylene glycol, water, cyclopentasiloxane, dimethicone/ vinyl dimethicone crosspolymer, hydroxyethyl acrylate/sodium acryloyl dimethyl taurate copolymer, cyclohexasiloxane, 1,2-hexanediol, caprylyl glycol and fragrance (aroma). The personal lubricant is packaged in a 100 mL tube or a 5 mL sample sachet. The device specifications for the LifeStyles® SKYN® Intimate Moments Personal Lubricant include appearance, color, odor, viscosity, specific gravity, osmolality, pH, total aerobic microbial count per USP<61>, total yeast and mold count per USP<61>, absence of specific microorganisms per USP<62>, and antimicrobial effectiveness per USP <51>. The device is not a contraceptive or spermicide, nor does it contain any such component. It is compatible with polyisoprene condoms but not compatible with natural rubber latex or polyurethane condoms.
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