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510(k) Data Aggregation
K Number
K233111Device Name
ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC
Manufacturer
Foshan United Medical Technologies, Ltd.
Date Cleared
2024-05-24
(240 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Foshan United Medical Technologies, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx Only (Pad and Ribbon Configurations)
Under the supervision of a healthcare professional, ALGS2 Ag Alginate Wound Dressing may be used for the management of acute and chronic, partial and full thickness wounds including pressure ulcers, leg ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, partial thickness burns.
For Over-the-Counter use (Pad Configuration)
ALGS2 Ag Alginate Wound Dressing may be used for
. Minor Abrasions
Minor Lacerations
. Minor cuts
. Minor scalds and burns
Device Description
ALGS2 Ag Alginate Wound Dressing is a soft, highly absorbent, sterile, single use, nonwoven (Rx version pad or ribbon, OTC version pad only) dressing composed of calcium alginate and 0.95% ionic silver which allows for a maximum of 18 mg of silver for a 4 inch x 4 inch dressing. The silver present in the dressing is to prevent or inhibit growth of bacteria within the dressing absorbs wound fluid and creates a soft and cohesive gel which conforms to the wound surface and assists in maintaining a moist environment. The ALGS2 Ag Alginate Wound Dressing helps maintain a moist wound environment which is conducive to wound healing.
The ALGS2 Ag Alginate Wound Dressing is individually packaged in foil pouches and terminally sterilized by gamma radiation.
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K Number
K172570Device Name
ALGS6 Ag Alginate Wound Dressing
Manufacturer
Foshan United Medical Technologies, Ltd.
Date Cleared
2018-05-11
(256 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Foshan United Medical Technologies, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx Only (Pad and ribbon Configurations)
Under the supervision of a healthcare professional, ALGS6 Ag Alginate Wound Dressing may be used for management of acute and chronic, partial and full thickness wounds including pressure ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second-degree burns.
For Over-the-Counter use (Pad Configuration), ALGS6 Ag Alginate Wound Dressing may be used for:
- Minor Abrasions
- Minor Lacerations
- Minor cuts
- Minor scalds and burns
Device Description
ALGS6 Ag Alginate Wound Dressing is a highly absorbent, sterile, single use, nonwoven (Rx version pad or ribbon, OTC version pad) dressing composed of calcium alginate fiber, Lyocell fiber and 1.7% ionic silver which allows for a maximum of 30.6 mg of silver for a 4-inch dressing (0.306 mg per square centimeter). Silver is present in the dressing as a preservative to prevent or inhibit growth of bacteria within the dressing. The dressing absorbs high amounts of wound fluid and the bacteria contained in the wound fluid. The absorbed wound fluid in the dressing creates a soft and cohesive gel which assists in maintaining a moist environment. The moist wound healing environment and control of dressing bacteria supports the body's healing process.
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