SHA

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Solid Wound Dressing With Permanently Bound Antimicrobial Agent

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4013

Medical specialty

General, Plastic Surgery

FDA 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.

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