DeviceClearance

Product code QSO— General, Plastic Surgery

PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2 +1 more

Classification name
Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
Device class
Class 2
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QSO under 21 CFR 878.4040, via openFDA

Market context for product code QSO

FDA has cleared 1 device under product code QSO, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QSO

Recent clearances under product code QSO

Data sourced from openFDA. This site is unofficial and independent of the FDA.