Data / Medical devices / Condom

Condom (HIS): 46 FDA-registered makers in 8 countries

46 establishments in 8 countries are registered with the FDA to make Condom (product code HIS, Class 2, 21 CFR 884.5300). 38 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 402 510(k) clearances under this code, the latest on September 21, 2026, and lists 7 recall events (0 Class I). FDA data exported November 3, 2026.

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Product code

HIS

Device class

2

Regulation

884.5300

Medical specialty

Obstetrics/Gynecology

Makers by country

Makers of Condom

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 September 21, 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.