Data / Medical devices / India / Suretex Prophylactics (India) Private Limited
Suretex Prophylactics (India) Private Limited: FDA-registered device maker in BANGALORE Karnataka, India, 12 510(k) clearances
Suretex Prophylactics (India) Private Limited is registered with the FDA (registration 9613932) in BANGALORE Karnataka, India. It lists 3 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 27, 2023. Registered through 2026. 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.
- FDA registration number
- 9613932
- FEI number
- 3001687671
- Address
- Plot No. 74-91 KIADB Industrial Estate Jigani II Phase, Anekal Taluk, BANGALORE Karnataka, India, 560105
- Owner or operator
- Suretex Prophylactics (India) Private Limited (9029871)
- Roles
- Manufacturer
- First device listed
- March 18, 2008
- Registered through
- 2026
- Brand names listed
- Adam & Eve - Marathon condoms, BARE RIDER CONDOM, HOT RIDER, LIFESTYLES ASSORTED COLORS, LIFESTYLES ASSORTED FLAVORS LATEX CONDOM, LIFESTYLES EXTRA STRENGTH CONDOM, LIFESTYLES LARGE CONDOM, LIFESTYLES LUBRICATED LATEX CONDOM and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Manufacturer | accessdata.fda.gov |
| Condom With Nonoxynol-9 | LTZ | 2 | Manufacturer | accessdata.fda.gov |
| Condom, Synthetic | MOL | 2 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 27, 2023 | K231908 | 45 Micron Polyisoprene Condom | MOL | Substantially Equivalent | Suretex Limited | accessdata.fda.gov |
| August 2, 2017 | K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | MOL | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| January 23, 2017 | K163107 | Lifestyles Zero Lubricated Latex Male Condom | HIS | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| July 25, 2016 | K160399 | Skyn Original Polyisoprene Lubricated Male Condom | MOL | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| April 17, 2003 | K030176 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT | HIS | Substantially Equivalent | Suretex, Ltd. | accessdata.fda.gov |
| April 27, 2001 | K010371 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT | HIS | Substantially Equivalent | Suretex, Ltd. | accessdata.fda.gov |
| July 31, 2000 | K001883 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM | HIS | Substantially Equivalent | Ansell Healthcare, Inc. | accessdata.fda.gov |
| April 19, 2000 | K000408 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM | HIS | Substantially Equivalent | Suretex Prophylactics , Ltd. | accessdata.fda.gov |
| August 19, 1999 | K992081 | VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL | HIS | Substantially Equivalent | Suretex Prophylactics (India) , Ltd. | accessdata.fda.gov |
| December 6, 1995 | K941258 | LATEX CONDOM | HIS | Substantially Equivalent | Suretex, Ltd. | accessdata.fda.gov |
| May 18, 1995 | K942858 | LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) | HIS | Substantially Equivalent | Suretex, Ltd. | accessdata.fda.gov |
| January 30, 1995 | K940046 | NON-LUBRICATED CONDOM | HIS | Substantially Equivalent | Ansell, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 27, 2023. 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.