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Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

Page Type
Product Code
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 and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4015
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive

§ 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.

(a) Identification. A wound dressing with pDADMAC additive is intended for use as a primary dressing for exuding wounds, 1st and 2d degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing.

(b) Classification. Class II (special controls). The special control is: the FDA guidance document entitled “Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive.” See § 878.1(e) for availability of this guidance document.

[74 FR 53167, Oct. 16, 2009]

Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

Page Type
Product Code
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 and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4015
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive

§ 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.

(a) Identification. A wound dressing with pDADMAC additive is intended for use as a primary dressing for exuding wounds, 1st and 2d degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing.

(b) Classification. Class II (special controls). The special control is: the FDA guidance document entitled “Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive.” See § 878.1(e) for availability of this guidance document.

[74 FR 53167, Oct. 16, 2009]