Silicone PHMB Foam Dressing
510(k) Number:
K192463
Indications for Use:
The Silicone PHMB Foam Dressing 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 is 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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