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Data / Medical devices / Condom / India

FDA-registered makers of Condom in India: 8 establishments

8 establishments in India are registered with the FDA to make Condom (product code HIS). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Device
Condom
Product code
HIS
Country
India

Makers of Condom in India

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Suretex Prophylactics (India) Private LimitedBANGALORE Karnataka, IndiaManufacturer9January 23, 2017000api.fda.gov
Indus Medicare Private LimitedMedak District Telangana, IndiaManufacturer8August 19, 2005000api.fda.gov
TTK Healthcare Limited - Protective Devices DivisionVIRUDHUNAGAR Tamil Nadu, IndiaManufacturer5September 7, 2023000api.fda.gov
TTK Healthcare LimitedPuducherry, IndiaContract manufacturer, Manufacturer5September 7, 2023000api.fda.gov
HLL Lifecare LimitedTHIRUVANANTHAPURAM Kerala, IndiaManufacturer1December 18, 1991000api.fda.gov
Raymond Lifestyle LimitedAURANGABAD Maharashtra, IndiaManufacturer1September 14, 1994000api.fda.gov
Cupid Ltd.NASHIK Maharashtra, IndiaContract manufacturer0000api.fda.gov
Penta Latex LLPHaridwar Uttarakhand, IndiaContract manufacturer0000api.fda.gov

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.