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510(k) Data Aggregation

    K Number
    K121898
    Device Name
    STAY FRESH SKIN FOLD MANAGEMENT TEXTILE
    Manufacturer
    QUICK-MED TECHNOLOGIES, INC.
    Date Cleared
    2013-05-24

    (329 days)

    Product Code
    FRL
    Regulation Number
    880.5300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stay Fresh Skin Fold Management Textile is a skin protectant intended to be used between skin folds and in other skin contact areas to provide moisture management and reduce friction. The Stay Fresh Skin Fold Management Textile contains hydrogen peroxide, which reduces bacterial populations in the fabric.
    Device Description
    Stav Fresh Skin Fold Management Textile is a non-sterile skin protectant indicated for management of skin folds and other skin-to-skin contact areas, such as extremities, and is offered as a 25.4 cm x 365.8 cm fabric piece (other sizes may also be available). The device provides moisture management to keep skin dry and the device's low coefficient of friction reduces skin-to-skin friction. Stay Fresh Skin Fold Management Textile is a single patient use product that is custom cut from a multiuse package. Polyester fabrics are well known to wick moisture away from skin as well as provide a low friction surface.
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    K Number
    K110715
    Device Name
    INTERDRY SILVER
    Manufacturer
    MILLIKEN HEALTHCARE PRODUCTS, LLC
    Date Cleared
    2011-11-04

    (234 days)

    Product Code
    FRL
    Regulation Number
    880.5300
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    Matched: '880.5300'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InterDry Textile is a skin protectant indicated for management of skin folds and other skin-to-skin contact areas. InterDry Textile reduces microbial colonization in the fabric.
    Device Description
    InterDry is a non-sterile skin protectant fabric with an antimicrobial silver complex. InterDry is a single patient use product that is custom cut from a multiuse package.
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    K Number
    K080978
    Device Name
    WALGREEN'S PERSONAL LUBRICATING JELLY
    Manufacturer
    TOPCO SALES
    Date Cleared
    2009-04-23

    (381 days)

    Product Code
    NUC
    Regulation Number
    884.5300
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    Matched: '880.5300'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Walgreen's Personal Lubricating Jelly 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. It can ease insertion of rectal thermometers, enemas and tampons. This product is compatible with latex condoms.
    Device Description
    Walgreen's Personal Lubricating Jelly is a non-sterile, aqueous based personal lubricant designed to supplement the body's own natural lubrication fluids. It is specifically formulated to be a clear, nonirritating, non-greasy, gel-like liquid and is compatible for use with or without a condom during intimate sexual activity as evidenced by condom compatibility test results. Walgreen's Personal Lubricating Jelly is a water-based personal lubricant containing chlorhexidine digluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water. This product is designed in LDPE tube w/ plastic flip-top cap.
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    K Number
    K061615
    Device Name
    INTERDRY TEXTILE WITH SILVER
    Manufacturer
    MILLIKEN CHEMICAL
    Date Cleared
    2006-12-22

    (196 days)

    Product Code
    FRL
    Regulation Number
    880.5300
    Why did this record match?
    Search-Everything :

    Matched: '880.5300'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InterDry Textile with Silver is a skin protectant indicated for management of skin folds and other skin-to-skin contact areas. InterDry Textile with Silver reduces microbial colonization in the fabric.
    Device Description
    Interdry Textile with Silver is a non-sterile skin protectant comprised of polyester knit textile substrate indicated for management of skin folds and other skin-to-skin contact areas and is offered as a 25.4 cm x 365.8 cm fabric piece, although other sizes may be available. The device provides moisture management to keep skin dry and the device's low coefficient of friction reduces skin-to-skin friction. Interdry Textile with Silver is a single patient use product that is custom cut from a multiuse package.
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