PHMB Foam Dressing Non-Adhesive
510(k) Number:
K192463
Indications for Use:
The
PHMB Foam Dressing Non-Adhesive 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
PHMB Foam Dressing Non-Adhesive is a sterile, single-use dressing, the
polyurethane foam contains 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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