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510(k) Data Aggregation

    K Number
    K050211
    Device Name
    PERSONAL WARMING GEL
    Manufacturer
    QUALIS, INC.
    Date Cleared
    2005-03-17

    (45 days)

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

    QUALIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Personal Warming Gel is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms
    Device Description
    Personal Warming Gel is a non-sterile, clear, non-staining, nongreasy, liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity.
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    K Number
    K050212
    Device Name
    PERSONAL WARMING JELLY
    Manufacturer
    QUALIS, INC.
    Date Cleared
    2005-03-17

    (45 days)

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

    QUALIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Personal Warming Jelly is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms.
    Device Description
    Personal Warming Jelly is a non-sterile, clear, non-staining, I ersonal walling Jelly used as a personal lubricant. This non groups, inquily lubricous and may be used with or without a latex condom during intimate sexual activity.
    Ask a Question
    K Number
    K041129
    Device Name
    PERSONAL LUBRICATING GEL
    Manufacturer
    QUALIS, INC.
    Date Cleared
    2004-09-24

    (147 days)

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

    QUALIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Personal Lubricating Gel is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms.
    Device Description
    Personal Lubricating Gel is a non-sterile, clear, non-staining, non-greasy, liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity.
    Ask a Question
    K Number
    K040085
    Device Name
    PERSONAL WARMING LUBRICANT
    Manufacturer
    QUALIS, INC.
    Date Cleared
    2004-04-20

    (95 days)

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

    QUALIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Personal Warming Lubricant is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms
    Device Description
    Personal Warming Lubricant is a non-sterile, clear, nonstaining, 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 condom during intimate sexual activity.
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    K Number
    K973780
    Device Name
    PERSONAL LUBRICATING LIQUID
    Manufacturer
    QUALIS, INC.
    Date Cleared
    1997-11-26

    (54 days)

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

    QUALIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Personal Lubricating Liquid is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms.
    Device Description
    Lubricating Liquid is a water-based, nonsticky. Personal nonstaining personal lubricant that is compatible with condoms and diagrams.
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    K Number
    K973557
    Device Name
    LUBRIGLIDE
    Manufacturer
    QUALIS, INC.
    Date Cleared
    1997-10-10

    (21 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUALIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lubriglide is a non-sterile personal lubricant for over-the-counter use. Its primary use is to apply the product to the genital area to reduce the discomfort associated with sexual activity. Lubriglide can also be used to lubricate rectal thermometers, tampons, douches, and enemas.
    Device Description
    Lubriglide is a water-based, water-soluble personal lubricant designed to imitate the body's own lubricating fluids. It is nonirritating, non-staining, and won't dry out or leave behind any solid residues. Lubriglide is non-toxic and is easily removed with water.
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