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510(k) Data Aggregation

    K Number
    K091554
    Device Name
    PHARMAPAC PERSONAL LUBRICANT
    Manufacturer
    Date Cleared
    2009-08-07

    (72 days)

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

    PHARMAPAC LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Lubricating 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, polyisoprene, and polyurethane condoms.
    Device Description
    PharmaPac Personal Lubricant is a water-based personal lubricant formulated to be a non-greasy, non-sticky, non-staining clear gel-like liquid. The water-soluble formula allows this product to be rinsed off with water.
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    K Number
    K070623
    Device Name
    PHARMAPAC LUBRICATING JELLY
    Manufacturer
    Date Cleared
    2007-08-31

    (178 days)

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

    PHARMAPAC LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Lubricating Jelly Personal Lubricant is primarily intended for personal lubrication, and eases insertion of rectal thermometers, enemas, and tampons and similar type nozzles. It is also compatible with latex condoms.
    Device Description
    PharmaPac Lubricating Jelly is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.
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    K Number
    K052974
    Device Name
    WARMING LIQUID PERSONAL LUBRICANT
    Manufacturer
    Date Cleared
    2005-12-16

    (53 days)

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

    PHARMAPAC LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Warming Liquid Personal Lubricant is primarily intended as a personal lubricant to warming bigule I crocion, and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal or penile tissue for purposes of lubrication, and moisturization. It is also compatible with latex condoms.
    Device Description
    PharmaPac Warming Liquid is a non-sterile, clear, non-staining, non-greasy, liquid I harmal as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity. Warming Liquid with or without a later of a contraceptive or spermicide. It is compatible with latex condoms.
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