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Data / Medical devices / Thailand / Suretex, Ltd.

Suretex, Ltd.: FDA-registered device maker in Amphur Phunphin Surat Thani, Thailand, 24 510(k) clearances

Suretex, Ltd. is registered with the FDA (registration 8040641) in Amphur Phunphin Surat Thani, Thailand. It lists 4 device types. The FDA files 24 510(k) clearances under its listings, the newest dated November 18, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Suretex, Ltd.
FDA registration number
8040641
FEI number
3002808272
Address
31/1 Moo 4, Suratthani-Thakuapha Road Tambon Khao Hua Kwai, Amphur Phunphin Surat Thani, Thailand, 84130
Owner or operator
SURETEX, LTD. (9010022)
Roles
Manufacturer, Specification developer
First device listed
March 27, 2008
Registered through
2026
Brand names listed
Adam & Eve - Hard Rider, Adam & Eve - Marathon condom, Adam & Eve - Marathon condoms, Adam & Eve - Ribbed, Adam & Eve - Ultra Thin, BARE RIDER, BULK (TESTED)-DOTTED, BULK (TESTED)-PINK COLOUR and more

Devices it lists

DeviceProduct codeClassRoleSource
CondomHIS2Manufacturer, Specification developeraccessdata.fda.gov
Condom With Nonoxynol-9LTZ2Manufactureraccessdata.fda.gov
Condom, SyntheticMOL2Manufactureraccessdata.fda.gov
Lubricant, PersonalNUC2Manufacturer, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 18, 2025K252521LifeStyles® HydraFeel Natural Rubber Latex CondomHISSubstantially EquivalentSuretex Limitedaccessdata.fda.gov
May 9, 2024K232470Polyisoprene Extra Large CondomMOLSubstantially EquivalentSuretex Limitedaccessdata.fda.gov
October 27, 2023K23190845 Micron Polyisoprene CondomMOLSubstantially EquivalentSuretex Limitedaccessdata.fda.gov
October 5, 2023K232279LifeStyles NRL Textured CondomHISSubstantially EquivalentSuretex Limitedaccessdata.fda.gov
September 30, 2022K221243OFNat Lubricant (L15)NUCSubstantially EquivalentSuretex Limitedaccessdata.fda.gov
April 28, 2022K213921Microthin Natural Rubber Latex CondomHISSubstantially EquivalentSuretex Limitedaccessdata.fda.gov
December 6, 2018K182438Synthetic Polyisoprene Lubricated Male Condom - 5 sensesMOLSubstantially EquivalentSxwell USA, LLCaccessdata.fda.gov
December 15, 2017K172473LifeStyles® SKYN® Intimate Moments Personal LubricantNUCSubstantially EquivalentSxwell USA, LLCaccessdata.fda.gov
August 2, 2017K171172Skyn Original Polyisoprene Lubricated Male Condom - FlavoredMOLSubstantially EquivalentAnsell Healthcare Products, LLCaccessdata.fda.gov
January 23, 2017K163107Lifestyles Zero Lubricated Latex Male CondomHISSubstantially EquivalentAnsell Healthcare Products, LLCaccessdata.fda.gov
July 25, 2016K160399Skyn Original Polyisoprene Lubricated Male CondomMOLSubstantially EquivalentAnsell Healthcare Products, LLCaccessdata.fda.gov
March 7, 2013K122476LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANTNUCSubstantially EquivalentAnsell Healthcare Products, LLCaccessdata.fda.gov
February 22, 2013K122720LIFESTYLES WARM LOVIN PERSONAL LUBRICANTNUCSubstantially EquivalentAnsell Healthcare Products, LLCaccessdata.fda.gov
February 19, 2013K122477LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANTNUCSubstantially EquivalentAnsell Healthcare Products, LLCaccessdata.fda.gov
February 14, 2013K122054LIFESTYLES NATURAL PERSONAL LUBRICANTNUCSubstantially EquivalentAnsell Healthcare Products, LLCaccessdata.fda.gov
December 19, 2003K033076LIFESTYLES LIQUID PERSONAL LUBRICANTHISSubstantially EquivalentAnsell Healthcare, Inc.accessdata.fda.gov
April 17, 2003K030176LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANTHISSubstantially EquivalentSuretex, Ltd.accessdata.fda.gov
April 27, 2001K010371LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANTHISSubstantially EquivalentSuretex, Ltd.accessdata.fda.gov
July 31, 2000K001883LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOMHISSubstantially EquivalentAnsell Healthcare, Inc.accessdata.fda.gov
April 19, 2000K000408LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOMHISSubstantially EquivalentSuretex Prophylactics , Ltd.accessdata.fda.gov
August 19, 1999K992081VARIOUS ANSELL TRADENAMES OR PRIVATE LABELHISSubstantially EquivalentSuretex Prophylactics (India) , Ltd.accessdata.fda.gov
December 6, 1995K941258LATEX CONDOMHISSubstantially EquivalentSuretex, Ltd.accessdata.fda.gov
May 18, 1995K942858LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)HISSubstantially EquivalentSuretex, Ltd.accessdata.fda.gov
January 30, 1995K940046NON-LUBRICATED CONDOMHISSubstantially EquivalentAnsell, Inc.accessdata.fda.gov

Compare with other makers

Updated November 18, 2025. 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.