Data / Medical devices / Non-Surgical Gown

Non-Surgical Gown (OEA): 440 FDA-registered makers in 24 countries

440 establishments in 24 countries are registered with the FDA to make Non-Surgical Gown (product code OEA, Class 1, 21 CFR 878.4040). 0 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

OEA

Device class

1

Regulation

878.4040

Medical specialty

General, Plastic Surgery

Makers by country

Makers of Non-Surgical Gown

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.