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Silicone PHMB Foam Dressing with Border

Silicone PHMB Foam Dressing with Border

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Silicone PHMB Foam Dressing with Border


510(k) Number:

K192463

 

Indications for Use:

The Silicone PHMB Foam Dressing with Border is indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.


Description:

The Silicone PHMB Foam Dressing with Border is a sterile, single-use dressings, the polyurethane foam contain about 0.5% (w/w) Polyhexamethylene Biguanide (PHMB), an agent that is intended to resist bacterial colonization within the dressing. The foam in the dressings has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment. Based on in vitro performance data, the PHMB Foam Wound Dressings have demonstrated to be effective against colonization and proliferation of bacteria within the dressing for up to 7 days.

 


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