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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device solid wound dressing with permanently bound antimicrobial agent
Definition A solid wound dressing with permanently bound antimicrobial agent consists of a solid wound dressing containing antimicrobial permanently bound to the substrate surface. The solid wound dressing is used to cover and protect a wound, to absorb exudate, and to maintain appropriate moisture balance within the wound and is intended for use only on external cutaneous (skin) wounds. The solid wound dressing is provided sterile in a form able to hold structural integrity. Antimicrobials are used for protectant purposes only to reduce microbial growth within the solid wound dressing while in use, or to provide an antimicrobial barrier to microbial penetration through the solid wound dressing. This classification does not include solid wound dressings containing a medically important antimicrobial as defined in the special controls.
Product CodeSHA
Regulation Number 878.4013
Device Class 2


Premarket Reviews
ManufacturerDecision
AMFERIA AB
  GRANTED 1

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