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510(k) Data Aggregation

    K Number
    K052162
    Device Name
    SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT
    Manufacturer
    SHEFFIELD LABORATORIES, DIV. OF FARIA LIMITED, LLC
    Date Cleared
    2006-02-06

    (181 days)

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

    SHEFFIELD LABORATORIES, DIV. OF FARIA LIMITED, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sheffield's Warming LubriGel Personal Lubricant (formula number 3120) is an over-the-counter personal lubricant intended to be used with or without a condom. Sheffield's Warming LubriGel is specially formulated to help supplement the body's natural lubricating fluids and to reduce friction during sexual intimacy. This lubricant may be safely applied to vaginal, anal or penile tissues for the purpose of lubrication and provides a mild warming sensation when applied to the genital area. This product is compatible with latex condoms.
    Device Description
    Warming LubriGel Personal Lubricant is a non-sterile, clear, colorless, odorless, non-greasy, non-staining, non-irritating personal lubricant. It is a water soluble, high viscosity gel-like liquid for use as a personal lubricant. This product provides a gentle warming sensation upon application, according to consumer's need for a lubricant that does not dry out. It is water-soluble and easily rinsed off with water. It is compatible with latex condoms as demonstrated in the Condom Compatibility Study conducted according to the standards as defined by ASTM D 3492-03. The product is packaged in a convenient laminate tube with a flip top cap and peel seal.
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    K Number
    K001077
    Device Name
    LUBRIGEL PERSONAL LUBRICANT
    Manufacturer
    SHEFFIELD LABORATORIES, DIV. OF FARIA LIMITED, LLC
    Date Cleared
    2000-08-02

    (120 days)

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

    SHEFFIELD LABORATORIES, DIV. OF FARIA LIMITED, LLC

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