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510(k) Data Aggregation
K Number
K143335Device Name
Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
Manufacturer
Roosin Medical Devices Co., Ltd
Date Cleared
2015-06-01
(193 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Roosin Medical Devices Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription:
Roosin Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including postoperative wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites
OTC:
First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.
Device Description
Roosin Silver Calcium Alginate Dressing/ Roosin Alginate Dressing with Preservative is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate and silver particles, which absorbs wound exudate and releases silver in the presence of wound fluid. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
The alginate material consists of silver that controls bacterial growth within the dressing. Based on in vitro laboratory testing, the silver has been shown to protect the dressing against both Gram positive and Gram negative bacteria, such as Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus pyogenes. The in vitro test was for one day only, so the user is advised to change the dressing every day for antibacterial preservative use.
The dressing has an off-white appearance and is available in the form of pad and in three different sizes (50 mm x 50 mm, 60 x 70 mm, 100 mm, 100 mm, 100 mm x 150 mm, and 20 mm x 300 mm), packaged in pouches. Additional sizes may also be manufactured per customer request. All dressings have the exactly the same material, chemical, and physical properties and are different only in size.
All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
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