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510(k) Data Aggregation
K Number
K061615Device Name
INTERDRY TEXTILE WITH SILVER
Manufacturer
MILLIKEN CHEMICAL
Date Cleared
2006-12-22
(196 days)
Product Code
FRL
Regulation Number
880.5300Why 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
K051445Device Name
MILLIKEN SILVER WOUND DRESSINGS
Manufacturer
MILLIKEN CHEMICAL
Date Cleared
2005-08-22
(81 days)
Product Code
FRO
Regulation Number
N/AWhy 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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