Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K033076
    Device Name
    LIFESTYLES LIQUID PERSONAL LUBRICANT
    Manufacturer
    ANSELL HEALTHCARE, INC.
    Date Cleared
    2003-12-19

    (81 days)

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

    ANSELL HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LifeStyles® Liquid Personal Lubricant is principally intended as personal lubricant to supplement the body's natural lubrication fluids, to moisturize, and to enhance the comfort and ease of intimate sexual activity with or without a latex condom.
    Device Description
    LifeStyles® Liquid Personal Lubricant is a non-sterile, water-based personal lubricant designed to supplement the body's natural lubrication fluids. The formula is a non-greasy, non-sticky, non-staining and non-irritating gel-like liquid that is compatible with latex condoms in laboratory testing. LifeStyles® Liquid Personal Lubricant is available over-the-counter in three formulas: LifeStyles® Liquid Personal Lubricant Long Lasting LifeStyles® Liquid Personal Lubricant Aloe & Vitamin E LifeStyles® Liquid Personal Lubricant Strawberry. The product is packaged in a plastic tube with a flip-top cap or in an aluminum foil/plastic film laminate sachet.
    Ask a Question
    K Number
    K001883
    Device Name
    LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
    Manufacturer
    ANSELL HEALTHCARE, INC.
    Date Cleared
    2000-07-31

    (40 days)

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

    ANSELL HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1