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