Company · TH
Suretex Limited
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2025. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 18, 2025 | K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom Suretex Limited, TH | HIS |
| May 9, 2024 | K232470 | Polyisoprene Extra Large Condom Suretex Limited, TH | MOL |
| Oct 27, 2023 | K231908 | 45 Micron Polyisoprene Condom Suretex Limited, TH | MOL |
| Oct 5, 2023 | K232279 | LifeStyles NRL Textured Condom Suretex Limited, TH | HIS |
| Sep 30, 2022 | K221243 | OFNat Lubricant (L15) Suretex Limited, TH | NUC |
| Apr 28, 2022 | K213921 | Microthin Natural Rubber Latex Condom Suretex Limited, TH | HIS |
| Apr 17, 2003 | K030176 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT Suretex, Ltd. | HIS |
| Apr 27, 2001 | K010371 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT Suretex, Ltd. | HIS |
| Dec 6, 1995 | K941258 | LATEX CONDOM Suretex, Ltd., TH | HIS |
| May 18, 1995 | K942858 | LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) Suretex, Ltd., TH | HIS |
| Jun 4, 1991 | K910284 | CONDOMS (RUBBER CONTRACEPTIVES) Suretex, Ltd. | HIS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||