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    K Number
    K040340
    Device Name
    K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT
    Manufacturer
    PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC
    Date Cleared
    2004-04-28

    (77 days)

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

    PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Personal Lubricant For vaginal/penile and condom application during sexual intimacy
    Device Description
    K-Y® Brand WARMING UltraGEL is a non-sterile, clear, non-staining, non-greasy, water soluble gel for use as a personal lubricant. This product imparts a gentle warming sensation when applied to the genitalia. This product was designed to meet a customer need for an intimate lubricant that does not feel cold when applied. K-Y® Brand Warming UltraGEL can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards as defined by ASTM D 3492. K-Y® Brand WARMING UltraGel is not a contraceptive nor spermicide.
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    K Number
    K040164
    Device Name
    K-Y BRAND WARMING JELLY PERSONAL LUBRICANT
    Manufacturer
    PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC
    Date Cleared
    2004-04-05

    (70 days)

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

    PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Personal Lubricant For vaginal/penile and condom application during sexual intimacy
    Device Description
    Description of Delly is a non-sterile, clear, non-staining, non-greasy, water soluble ielly for use as a personal lubricant. This product imparts a gentle warming sensation when Jen' for use as a personal nas designed to meet a customer need for a lubricant that does not feel cold when applied. K-Y® Brand Warming Jelly reduce can reduce friction that does not feel cold which upplives and intimacy. It is compatible with latex during sexual mercounse theres your Compatibility Testing conducted according the condonis as defined by ASTM D 3492. K-Y® Brand WARMING Jelly is not a contraceptive nor spermicide.
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