FDA product code QSO: Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
QSO is the FDA product code for medical gowns with chemotherapy labeling claims - tested for use with chemotherapy drugs. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. Devices under QSO reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs |
| Device class | Class II |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for QSO devices
openFDA lists no recalls for product code QSO.
Frequently asked questions
What is FDA product code QSO?
QSO is the FDA product code for medical gowns with chemotherapy labeling claims - tested for use with chemotherapy drugs. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is QSO?
Class II, regulation 21 CFR 878.4040. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QSO
- Run a recall and safety report across every QSO manufacturer
- Watch product code QSO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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