NYS — Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac) Class II

FDA Device Classification

Classification Details

Product Code
NYS
Device Class
Class II
Regulation Number
878.4015
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN070002quick-med technologiesQMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSINGFebruary 25, 2009