Data / Medical devices / Gown, Isolation, Surgical

Gown, Isolation, Surgical (FYC): 42 FDA-registered makers in 11 countries

42 establishments in 11 countries are registered with the FDA to make Gown, Isolation, Surgical (product code FYC, Class 2, 21 CFR 878.4040). 25 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 68 510(k) clearances under this code, the latest on May 16, 2024, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code

FYC

Device class

2

Regulation

878.4040

Medical specialty

General, Plastic Surgery

Makers by country

Makers of Gown, Isolation, Surgical

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 May 16, 2024. 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.