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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?
Applicant Name (Manufacturer) :
QUICK-MED TECHNOLOGIES, INC.
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
DEN070002Device Name
QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
Manufacturer
QUICK-MED TECHNOLOGIES, INC.
Date Cleared
2009-02-25
(657 days)
Product Code
NYS
Regulation Number
878.4015Why did this record match?
Applicant Name (Manufacturer) :
QUICK-MED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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