Device type
Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
Product code QSO · Class II · 21 CFR 878.4040 · General, Plastic Surgery
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.
Recent 510(k)s
Oct 28, 2026
K260310
HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD* Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL)
O&M Halyard, Inc.
- QSO
- Class II
Sep 1, 2026
K261811
PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)
PRIMED Medical Products, Inc.
- QSO
- Class II
Recent recalls
No recalls in the archive for QSO.