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Winner Silver Alginate Dressing has Obtained 510K Code in the USA

Winner Silver Alginate Dressing has Obtained 510K Code in the USA

02/03/2022

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Winner Medical

Winner Silver Alginate Dressing has Obtained 510K Code in the USA

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Winner Silver Alginate Dressing has Obtained 510K Code in the USA

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Recently, the silver alginate dressing of Winner Medical (300888.SZ) receives U.S. FDA market access(510K Number: K202982), marking that this product has obtained the qualification to get into the access US market and Winner Medical will further expand its business in North America.

It is understood that the silver alginate dressing is composed of calcium alginate and silver particles, which can absorb wound exudate and continuously release silver ions in the presence of wound fluid, and it can effectively kill and inhibit the microbial colonization of wounds. The antibacterial rate is 99.99%, and it can be used for up to 7 days. The alginate absorbs the wound exudate and forms a gel to maintain the moist environment of the wound.

This product has very distinctive features. It forms a gel after absorbing wound exudate to maintain a moist healing environment on the wound surface; it is broad-spectrum antibacterial and continuously releases silver ions with an effect of 99.99% and can be used for up to 7 days; silver alginate dressing is suitable for moderate to severe infected wounds, including postoperative wounds, trauma wounds, calf ulcers, pressure ulcers, diabetic ulcers, grafts and donor sites.

The FDA's approval of Winner Medical's silver alginate series products will be helpful to further improve market competitiveness in this field, and will play a positive role in promotion and product sales in overseas market.


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