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510(k) Data Aggregation

    K Number
    K130345
    Device Name
    AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING
    Manufacturer
    MAYER LABORATORIES, INC.
    Date Cleared
    2013-08-01

    (171 days)

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

    MAYER LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aqua Lube® Natural Personal Lubricant 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
    Aqua Lube® Natural Personal Lubricant is a non-sterile, water-based, personal lubricant designed to supplement the body's own natural lubrication fluids. Aqua Lube® Natural Personal Lubricant consists of two models: "Regular" and "Warming." This product is a clear, non-greasy, high-viscosity, liquid. This product is composed primarily of organic aloe, hydroxyethycellulose, sorbitol, and tocopherols (vitamin E). The Warming model contains the same ingredients as the Regular model plus the additional ingredient organic peppermint oil. Aqua Lube® Natural Personal Lubricant causes a warming response. This product may be used with or without a condom during intimate sexual activity. This product is packaged in a tube made of low density polyethylene with a polypropylene cap. Tube sizes included 1 oz., 2.5 oz, and 4.0 oz. Each tube is packaged in a paperboard carton, which constitutes the device's individual carton.
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    K Number
    K113686
    Device Name
    KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED
    Manufacturer
    MAYER LABORATORIES, INC.
    Date Cleared
    2012-03-06

    (82 days)

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

    MAYER LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Kimono MicroThin with Aqua Lube / Reality Ultra Lubricated condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is lubricated by a water based lubricant system. Typical (Average) Product Characteristics are as follows: • Straight walled, reservoir end • Nominal length (mm): 190mm+/-10mm • Nominal width (mm): 52 mm +/- 2mm • Nominal thickness (mm) .04 -0.01 Kimono MicroThin with Aqua Lube: .049mm +/- 0.01 Reality Ultra Lubricated: .065mm +/- 0.01mm
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    K Number
    K110325
    Device Name
    AQUA LUBE
    Manufacturer
    MAYER LABORATORIES, INC.
    Date Cleared
    2011-12-08

    (308 days)

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

    MAYER LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aqua Lube Personal Lubricant 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, polyisoprene, and polyurethane condoms.
    Device Description
    Aqua Lube® is a non-sterile, water-based, personal lubricant designed to supplement the body's own natural lubrication fluids. This product is a clear, non-greasy, high-viscosity, liquid. This product may be used with or without a condom during intimate sexual activity.
    Ask a Question

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