Suretex, Ltd.
Amphur Phunphin Surat Thani, TH
SURETEX, LTD. appears in FDA device records in Amphur Phunphin Surat Thani, TH. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Suretex, Ltd. between 1991 and 2025. The busiest year on record is 1995, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1995 | 2 |
| 2001 | 1 |
| 2003 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom | HIS | Substantially Equivalent | |
| K232470 | Polyisoprene Extra Large Condom | MOL | Substantially Equivalent | |
| K231908 | 45 Micron Polyisoprene Condom | MOL | Substantially Equivalent | |
| K232279 | LifeStyles NRL Textured Condom | HIS | Substantially Equivalent | |
| K221243 | OFNat Lubricant (L15) | NUC | Substantially Equivalent | |
| K213921 | Microthin Natural Rubber Latex Condom | HIS | Substantially Equivalent | |
| K030176 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT | HIS | Substantially Equivalent | |
| K010371 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT | HIS | Substantially Equivalent | |
| K941258 | LATEX CONDOM | HIS | Substantially Equivalent | |
| K942858 | LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) | HIS | Substantially Equivalent | |
| K910284 | CONDOMS (RUBBER CONTRACEPTIVES) | HIS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8040641 | 3002808272 | SURETEX, LTD. | 31/1 Moo 4, Suratthani-Thakuapha Road, Amphur Phunphin Surat Thani 84130 TH | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain