OEA — Non-Surgical Gown Class I
FDA product code OEA covers "Non-Surgical Gown", a Class I medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel.
Classification Details
- Product Code
- OEA
- Device Class
- Class I
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material