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U.S. Department of Health and Human Services

Product Classification
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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.
Physical State A wound dressing with permanently bound antimicrobial consists of a solid wound dressing containing antimicrobial permanently bound to the substrate surface. The solid wound dressing is provided sterile in a form able to hold structural integrity.
Technical Method Wound dressings can maintain a moist wound environment based on their ability to absorb and manage wound exudate levels. They can also provide an effective barrier to environmental contaminants by utilizing a mechanical barrier or an antimicrobial barrier to eliminate the penetration of external microorganisms. 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.
Target Area Skin wounds
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeSHA
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.4013
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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