Product code QSO
- Device name
- Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4040
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset