QSO

Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs

Product code
QSO
Device name
Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
Device class
Class 2
21 CFR
21 CFR 878.4040
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)

FDA classification definition

Medical gowns that are worn by healthcare personnel to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material. In addition, these gowns have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs.

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

Official FDA classification page: QSO
Classification and pathway per current FDA publications. Data from openFDA (CC0).