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510(k) Data Aggregation
K Number
K192478Device Name
LT Antibacterial Alginate with Silver Dressing
Manufacturer
Zhejiang Longterm Medical Technology Co., Ltd.
Date Cleared
2020-06-17
(281 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Zhejiang Longterm Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LT Antibacterial Alginate with Silver Dressing is used for management acute and chronic wounds, partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, surgical wounds, traumatic wounds, first and second-degree burns.
LT Antibacterial Alginate with Silver Dressing is intended for external use only.
Device Description
LT Antibacterial Alginate with Silver Dressing is an advanced wound care dressing composed of calcium alginate and silver salt (3.5%). The dressing forms a gel when absorbs wound fluid to provide a moist environment and allows intact removal. When in contact with wound fluid, silver ions within the dressing inhibit bacterial growth in the dressing. LT Antibacterial Alginate with Silver Dressing is available in pad and ribbon configurations and various sizes. The pad is used to cover and protect the wound bed and the ribbon is used to pack the wound with cavity.
LT Antibacterial Alginate with Silver Dressing can be cut and layered for various wound shapes and types.
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