Product code OEA
- Device name
- Non-Surgical Gown
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4040
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material
- Source
- FDA openFDA device classification dataset