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510(k) Data Aggregation

    K Number
    K141603
    Device Name
    Ultra Silver Dressings
    Manufacturer
    MILLIKEN HEALTHCARE PRODUCTS, LLC
    Date Cleared
    2014-10-22

    (128 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    **MILLIKEN **HEALTHCARE PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ULTRA Silver Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).
    Device Description
    The ULTRA Silver Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are comprised of 4 layers, each performing a specific function; an occlusive synthetic top layer, a polyurethane foam layer, a hot-melt adhesive and a layer of a silver-containing knitted composite fabric.
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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    **MILLIKEN **HEALTHCARE PRODUCTS, LLC

    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
    K103141
    Device Name
    LOW ADHERENT AFM AG DRESSINGS
    Manufacturer
    MILLIKEN HEALTHCARE PRODUCTS, LLC
    Date Cleared
    2011-01-21

    (88 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    **MILLIKEN **HEALTHCARE PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Low Adherent AFM Ag Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). The Low Adherent AFM Ag Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.
    Device Description
    The Low Adherent AFM Ag Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are designed to contact the wound as a primary dressing and permit the passage of fluids. The dressings provide a protective environment for the wound and an effective protection against microbial contamination in the dressing. The devices are effective antimicrobial barrier dressings against both Gram-positive and Gram-negative bacteria, including the following organisms: methicillin-resistant Staphylococcus aureus (MRSA). methicillin- resistant Staphylococcus epidermidis (MRSE), vancomycin-resistant Enterococcus faecalis (VRE), Pseudomonas aeruginosa, and Acinetobacter baumannii.
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    K Number
    K093188
    Device Name
    AFM ULTRA AG DRESSINGS
    Manufacturer
    MILLIKEN & CO.
    Date Cleared
    2010-02-17

    (131 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    **MILLIKEN **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AFM Ultra Ag Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, and Stage I-1V dermal ulcers (vascular, venous, pressure and diabetic).
    Device Description
    The AFM Ultra Ag Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are comprised of 4 layers, each performing a specific function; an occlusive synthetic top layer, a polyurethane foam layer, a hotmelt adhesive and a layer of a silver-containing knitted composite fabric.
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    K Number
    K083659
    Device Name
    SILVER WOUND PAD
    Manufacturer
    MILLIKEN & CO.
    Date Cleared
    2009-04-16

    (127 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    **MILLIKEN **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silver Wound Pad is indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, lymphoedema, dermatological wounds, and Stage I-IV dermal ulcers (vascular, arterial, venous, pressure and diabetic).
    Device Description
    The Silver Wound Pad is a sterile, single-use wound care dressing for use in moist wound management. The Silver Wound Pad is offered in several configurations including 24" x 36" and 36 " x 36" The dressings are comprised of 5 layers, each performing a specific function; an occlusive synthetic bottom layer (not in contact with patient), two absorbent layers, a layer of a knitted composite fabric (containing polyester on one side and nylon on the other side; coated with 15 ± 5% Antimicrobial AlphaSan® RC 2000 contained in a polyurethane binder) and a contact layer of apertured polyethylene film. These layers are then stitched or heat-sealed together along the edge.
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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?
    Applicant Name (Manufacturer) :

    **MILLIKEN **CHEMICAL

    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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    K Number
    K051445
    Device Name
    MILLIKEN SILVER WOUND DRESSINGS
    Manufacturer
    MILLIKEN CHEMICAL
    Date Cleared
    2005-08-22

    (81 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    **MILLIKEN **CHEMICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Milliken Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. Milliken Silver Wound Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).
    Device Description
    Milliken's Silver Wound Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressing consists of a nylon, lycra, and polyester continuous filament Jersey knit textile substrate which is pad coated with an aqueous suspension of silver sodium hydrogen zirconium phosphate (AlphaSan® RC-2000) and a polyurethane binder to provide an antimicrobial coating to the fabric. The textile substrate has a nylon face and polyester back providing a moisture affinity gradient across the thickness of the dressing. Milliken Silver Wound Dressings are offered in several configurations including the following: 2" x 2", 4.25" x 4.25", 6" x 6", 1" x 24" and 4" x 48" (wrap).
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