Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
NYS · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4015
Classification
FDA Product Code
NYS
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4015
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.