Data / Medical devices / Mask, Surgical

Mask, Surgical (FXX): 212 FDA-registered makers in 22 countries

212 establishments in 22 countries are registered with the FDA to make Mask, Surgical (product code FXX, Class 2, 21 CFR 878.4040). 171 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 607 510(k) clearances under this code, the latest on March 18, 2026, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

FXX

Device class

2

Regulation

878.4040

Medical specialty

General, Plastic Surgery

Makers by country

Makers of Mask, 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 March 18, 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.