Product Classification

• Device: wound dressing with poly(diallyl dimethyl ammonium chloride)(pdadmac)
• Regulation Description: Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
• Definition: A wound dressing with poly (diallyl dimethyl ammonium chloride) (pdadmac) additive is a device that is a sterile barrier wound dressing intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing.The device consists of a textile substrate and permanently bound pdadmac.The device acts as a physical barrier to outside contaminants and does not act on the surface or interior of the wound nor does it contain antimicrobial agents that act on the body.
• Physical State: Wound dressing
• Technical Method: Topical application
• Target Area: exuding Wounds and first and second degree burns
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: NYS
• Submission Type: 510(k)
• Regulation Number: 878.4015
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Document

• Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Wound Dressing with Poly(diallyl dimethyl ammonium chloride) (pDADMAC) Additive  

Third Party Review

Not Third Party Eligible