Product code
OEA: Non-surgical isolation gown
FDA product code · Class I · General Hospital
Key facts
| Product code | OEA |
|---|---|
| Device | Non-surgical isolation gown |
| Device class | Class I |
| Regulation number | 878.4040 |
| Review panel | General Hospital |
| Medical specialty | General & Plastic Surgery |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1,000+ UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 10–99 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database