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U.S. Department of Health and Human Services

Product Classification

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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 CodeNYS
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
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 [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm186571.htm] 
Third Party Review Not Third Party Eligible
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