NZP

Sealant, Microbial

Product code

NZP

Device name

Sealant, Microbial

Device class

Class 2

21 CFR

21 CFR 878.4370

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification definition

Intended to isolate the site of a surgical incision from microbial contamination and indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure.

Definition text from the FDA device classification database (U.S. federal government work, public domain).