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510(k) Data Aggregation

    K Number
    K203644
    Device Name
    Solevy Co. LLC Silicone Based Personal Lubricant
    Manufacturer
    Date Cleared
    2021-04-19

    (126 days)

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

    Solevy Co. LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Solevy Co. LLC Silicone Based Personal Lubricant is a silicone-based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Solevy Co. LLC Silicone-Based Personal Lubricant is a clear, colorless, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. The device is not compatible for use with polyurethane condoms. The device is a non-sterile lubricant, for penile and/or vaginal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is provided in volumes of 1, 2.5, 4.5, 8, and 16 fl. oz in polyethylene bottles. The 1-8 fl. oz. bottles are closed with polypropylene (PP) caps, while the 16 fl. oz. bottle includes a polypropylene lotion pump. The 16 fl. oz. bottle is sealed using tamper-resistant shrink wrap band. The 1-8 fl. oz. bottles are sealed using an induction seal constructed of aluminized mylar.
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    K Number
    K203654
    Device Name
    Solevy Co. LLC Water-Based Personal Lubricant
    Manufacturer
    Date Cleared
    2021-04-19

    (125 days)

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

    Solevy Co. LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Solevy Co. LLC Water-Based Lubricant is a water-based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, 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
    Solevy Co. LLC Water-Based Lubricant is a clear, colorless, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane, and polyisoprene. The device is a non-sterile lubricant, for penile and/or vaginal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication The product is provided in volumes of 1, 2.5, 4.5, 8, and 16 fl. oz in polyethylene bottles. The 1-8 fl. oz. bottles are closed with polypropylene (PP) caps, while the 16 fl. oz. bottle includes a polypropylene lotion pump. The 16 fl. oz. bottle is sealed using tamper-resistant shrink wrap band. The 1-8 fl. oz. bottles are sealed using an induction seal constructed of aluminized mylar.
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    Ask a specific question about this device

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