FDA product code OEA: Non-Surgical Gown
OEA is the FDA product code for non-surgical gown. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. Devices under OEA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 18 recalls for OEA devices, 2 initiated in the last five years.
Definition
A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material
Classification
| Field | Value |
|---|---|
| Device name | Non-Surgical Gown |
| Device class | Class I |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for OEA devices
18 product recalls in 6 recall events; 2 initiated in the last five years and 15 still open. Most recent: 2026-07-31.
| Year | Recalls |
|---|---|
| 2020 | 2 |
| 2021 | 13 |
| 2024 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code OEA?
OEA is the FDA product code for non-surgical gown. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is OEA?
Class I, regulation 21 CFR 878.4040. Typical premarket route: 510(k) exempt.
Have OEA devices been recalled?
Yes: 18 product recalls across 6 recall events; the most recent began 2026-07-31.
Next steps
- Run an FDA pathway report with predicate devices for product code OEA
- Run a recall and safety report across every OEA manufacturer
- Watch product code OEA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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