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510(k) Data Aggregation
K Number
K092826Device Name
ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL
Manufacturer
AMERICAN BIOTECH LABS
Date Cleared
2009-11-12
(59 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
AMERICAN BIOTECH LABS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ASAP® Silver Antibacterial Wound Dressing Gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.
Device Description
ASAP® Silver Antibacterial Wound Dressing Gel is a water based gel wound dressing that contains silver that in laboratory tests has been shown to inhibit the growth of microorganisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant strains, MRSA and VRE as well as fungi such as Candida albicans.
The high moisture content gel contains a base matrix composed of hydrophilic and buffering compounds and contains silver from American Biotech Labs' proprietary silver hydrosol suspension. ASAP® Antibacterial Silver Wound Dressing Gel is supplied in a multi-dose gel pump and a tube (collapsible, low-density polyethylene lined metal tube, sealed on one end and fitted with a pop-open screw cap on the other end).
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K Number
K082333Device Name
ASAP WOUND DRESSING GEL
Manufacturer
AMERICAN BIOTECH LABS
Date Cleared
2009-04-02
(231 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
AMERICAN BIOTECH LABS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.
Device Description
ASAP Wound Dressing Gel is an amorphous, water-based gel that contains silver hydrosol that may inhibit the growth of microorganisms within the dressing. The high moisture content gel contains a base matrix composed of hydrophilic and buffering compounds and contains silver from American Biotech Labs' proprietary silver hydrosol suspension. ASAP Wound Dressing Gel is supplied in a multi-dose gel pump and a tube (collapsible, low-density polyethylene tube, sealed on one end and fitted with a pop-open screw cap on the other end).
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