Product code SHA

Device name

Solid Wound Dressing With Permanently Bound Antimicrobial Agent

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4013

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset