Suretex, Ltd.
Suretex, Ltd. has 0 FDA recalls, 1 inspection, 11 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Feb 19, 2009 · VAI
- Latest 510(k)
- Nov 18, 2025
Reviewing Suretex, Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Suretex, Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 11 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 19, 2009 | Surat-Thani, Thailand | Devices | Voluntary Action Indicated (VAI) | 3002808272 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002808272 | Surat-Thani, Thailand | 1 | Feb 19, 2009 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom | Nov 18, 2025 |
| K232470 | Polyisoprene Extra Large Condom | May 9, 2024 |
| K231908 | 45 Micron Polyisoprene Condom | Oct 27, 2023 |
| K232279 | LifeStyles NRL Textured Condom | Oct 5, 2023 |
| K221243 | OFNat Lubricant (L15) | Sep 30, 2022 |
| K213921 | Microthin Natural Rubber Latex Condom | Apr 28, 2022 |
| K030176 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT | Apr 17, 2003 |
| K010371 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT | Apr 27, 2001 |
| K941258 | LATEX CONDOM | Dec 6, 1995 |
| K942858 | LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) | May 18, 1995 |
| K910284 | CONDOMS (RUBBER CONTRACEPTIVES) | Jun 4, 1991 |
Need more than this page shows? Ask about Suretex, Ltd. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.