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Found 4 results
510(k) Data Aggregation
K Number
K121898Device Name
STAY FRESH SKIN FOLD MANAGEMENT TEXTILE
Manufacturer
QUICK-MED TECHNOLOGIES, INC.
Date Cleared
2013-05-24
(329 days)
Product Code
FRL
Regulation Number
880.5300Why did this record match?
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Matched: '880.5300'
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
K110715Device Name
INTERDRY SILVER
Manufacturer
MILLIKEN HEALTHCARE PRODUCTS, LLC
Date Cleared
2011-11-04
(234 days)
Product Code
FRL
Regulation Number
880.5300Why did this record match?
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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
K080978Device Name
WALGREEN'S PERSONAL LUBRICATING JELLY
Manufacturer
TOPCO SALES
Date Cleared
2009-04-23
(381 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
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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
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?
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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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