工商备案号：粤工商备P131904000303 | 互联网药品信息服务资格证书（粤）—非经营性—2020—0083
FORYOU MEDICAL Receives 510(k) Clearance for its PHMB Alginate Dressing
LUOFUCON® PHMB Antibacterial Alginate Dressing is a sterile, single-use dressing consisting of calcium alginate fiber treated with PHMB，which is a brand new advanced wound care product. It solves the passivated problem of chemical reaction between alginate and PHMB, which provides safe and good 7-day antimicrobial activities for infected wounds. This dressing not only has alginate property of providing moist wound environment, but also offers PHMB advantage of highly effective safety.
Recently, FORYOU MEDICAL had receives 510(k) Clearance for this product, No.K201013, this represents a further enrich the product line of antibacterial dressings sold by FORYOU MEDICAL in the U.S.
Through years of technical research, FORYOU MEDICAL innovated Antibacterial Laboratory has invented the patented technology of PHMB antibacterial alginate fiber and the corresponding preparation method of antibacterial dressing. By grafting and loading PHMB on alginate fiber at the very beginning, the patented technology not only solves the technical problem of rapid passivation of antibacterial activity after mixing PHMB and alginate, but also overcomes the problem of easy free releasing of PHMB. It achieves long-term good antibacterial activity with low content, guarantees the antibacterial performance, and improves the safety and effectiveness. This technology has been patented in China, the United States and the European Union, the corresponding patent numbers are:CN107385917A, US 2019/0284727 A1, EP3660191 A1.
LUOFUCON® PHMB Alginate Dressing is indicated for the management of moderate to heavily exudating wounds, and partial to full thickness wounds, including postoperative wounds, first and second degree burns, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.
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