QSO — Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs Class II
FDA product code QSO covers "Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs", a Class II medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel.
Classification Details
- Product Code
- QSO
- Device Class
- Class II
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.