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510(k) Data Aggregation
K Number
K121522Device Name
POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)
Manufacturer
POLYREMEDY, INC.
Date Cleared
2012-06-27
(35 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
POLYREMEDY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Over-the-Counter Use, PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings may be used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns.
Under the supervision of a healthcare professional, PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings may be used for the management of:
PolyFIT+ Absorbing Antimicrobial Dressings are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ Absorbing Antimicrobial Dressings are for use as adjunctive treatment in the management of exudating wounds, partial and full-thickness wounds, such as pressure ulcers lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds (including those left open to heal by secondary intention). They are not intended for wounds with exposed tendon or bone, or for 30 degree burns.
Device Description
PolyFIT+ Absorbing Antimicrobial Dressings are soft, sterile dressings designed for the management of exudating wounds and are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ Absorbing Antimicrobial Dressings are made of synthetic, hvdrophilic, fibers embedded with a 0.3% concentration of Polyhexamethylene Biguanide (PHMB).
PolyRemedy employs an electrospinnng process to manufacture the ingredients: polyethylene oxide (PEO), polyethylene-co-vinyl-alcohol (EVOH), polycaprolactone (PCL) and PHMB into fibers, forming consistent and congruent dressings. Within the PolyFIT+ Absorbing Antimicrobial Dressings, the PEO gelling fibers are supported by the EVOH and PCL fibers for structural integrity. While absorbing wound exudate, the fibers transform from a dry dressing into a fiber gelling dressing that rapidly absorbs excess exudate away from the wound surface and retains it in the dressing. When exudate is absorbed into the PolyFIT+ Absorbing Antimicrobial Dressing, the PHMB embedded in the fibers ensures that when bacteria come in contact with the PHMB molecule the outer cell wall of the bacteria is disrupted, resulting in leakage of cytoplasm and cell death. As a consequence, bacterial numbers decrease, replication ceases and mutation cannot occur.
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K Number
K092348Device Name
POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS
Manufacturer
POLYREMEDY, INC.
Date Cleared
2010-04-08
(247 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
POLYREMEDY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PolyFIT+ High Hydrating Antimicrobial Dressings are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ High Hydrating Antimicrobial Dressings are indicated for use under a healthcare professional's orders as adjunctive treatment to maintain a moist wound environment in the management of dry wounds or wounds with minimal to no exudate, in the care of partial or full-thickness wounds, such as pressure ulcers (Stages II-IV), lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds (including those left open to heal by secondary intention). They are not intended for wounds with exposed tendon or bone and for 3rd degree byrns.
Device Description
Not Found
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K Number
K092351Device Name
POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS
Manufacturer
POLYREMEDY, INC.
Date Cleared
2010-04-08
(247 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
POLYREMEDY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PolyFIT+ Absorbing Antimicrobial Dressings are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ Absorbing Antimicrobial Dressings are for use under a healthcare professional's orders as adjunctive treatment in the management of exudating wounds, partial and full-thickness wounds, such as pressure ulcers (Stages II-IV), lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds (including those left open to heal by secondary intention). They are not intended for wounds with exposed tendon or bone, for 310 degree burns or for dry wounds.
Device Description
Not Found
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