Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
The Wound Dressing with Poly(Diallyl Dimethyl Ammonium Chloride) (PDADMAC) (product code NYS) is a sterile barrier wound dressing containing a permanently bound PDADMAC additive on a textile substrate, intended as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, as well as for securing primary dressings and wound packing. It acts as a physical barrier to external contaminants without releasing antimicrobial agents. Classified as FDA Class 2, it requires 510(k) clearance and is regulated under 21 CFR 878.4015 within the General and Plastic Surgery specialty.
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Basic Information
- Product Code
- NYS
- Device Class
- FDA class 2
- Regulation Number
- 878.4015
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN070002 | QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING | Feb 25, 2009 | Unknown | Quick-Med Technologies, Inc. |