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510(k) Data Aggregation

    K Number
    K160763
    Device Name
    ally Liquid Personal Lubricant
    Date Cleared
    2016-06-29

    (100 days)

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

    **GUY **& O'NEILL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ally® Liquid 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    ally® Liquid Personal Lubricant is a non-sterile, clear, non-staining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex or polyisoprene condom during intimate sexual activity. This product is not a contraceptive or spermicide. The product is packaged in 2 to 8 ounce plastic bottles with tamper-proof seals. INGREDIANTS: Purified water, propanediol, hydroxyethylcellulose, hydroxyacetophenone, lactic acid
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    K Number
    K160717
    Device Name
    ally Warming Liquid Personal Lubricant
    Date Cleared
    2016-06-14

    (91 days)

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

    **GUY **& O'NEILL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ally® Warming Liquid 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    The device is non-sterile, clear, non-staining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a natural rubber latex or polyisoprene condom during intimate sexual activity. This product is not a contraceptive or spermicide. The product is packaged in 2 to 8 ounce plastic bottles with tamperproof seals.
    Ask a Question

    Ask a specific question about this device

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