Non-Surgical Gown
The Non-Surgical Gown (product code OEA) is a general hospital protective garment intended to protect healthcare patients and personnel from the transfer of microorganisms, body fluids, and particulate material in non-surgical settings such as isolation precautions or general patient care. It differs from surgical gowns in that it is not designed to the higher barrier requirements of the sterile field. This device is FDA Class 1 under regulation 878.4040 in the General, Plastic Surgery specialty, subject only to general controls, and cleared through the De Novo pathway (submission type 4). It is not GMP-exempt and carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OEA
- Device Class
- FDA class 1
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material
FEI Numbers
This FDA classification entry is associated with 547 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 547 registration numbers. Click on an entry to view related FDA registrations.