# Suretex Limited

- Location (FDA's records): Tambon Khao Kwai, Amphur Phunphin, TH
- FDA decisions: 11 (1991–2025): 11 510(k) clearances
- Names in FDA's records: Suretex Limited (6); Suretex, Ltd. (5)
- Product codes: HIS (8), MOL (2), NUC (1)
- 510(k) review time since 2016: median 143 days, against 112 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 10 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ansell Healthcare Products, LLC: 4 (https://510kreport.com/company/ansell-healthcare-products)
- Shanghai Personage Hygiene Products Co., Ltd.: 1 (https://510kreport.com/company/shanghai-personage-hygiene-products)
- Okamoto USA, Inc.: 1 (https://510kreport.com/company/okamoto-usa)
- Suretex Prophylactics (India), Ltd.: 1 (https://510kreport.com/company/suretex-prophylactics-india)

## Firms that cite its devices most
- Ansell Healthcare Products, LLC: 2 (https://510kreport.com/company/ansell-healthcare-products)
- Suretex Prophylactics (India), Ltd.: 2 (https://510kreport.com/company/suretex-prophylactics-india)
- G. Premjee (Usa), Inc.: 2 (https://510kreport.com/company/g-premjee-usa)
- Unidus Corp.: 1 (https://510kreport.com/company/unidus)
- Thai Nippon Rubber Industry Co., Ltd.: 1 (https://510kreport.com/company/thai-nippon-rubber-industry)
- Tianjin Human-Care Latex Corporation: 1 (https://510kreport.com/company/tianjin-human-care-latex)

## Its most-cited devices
- K942858: Latex Condoms W/Spermicidal Lubricant (Nonoxynol-9) (1995), cited by 4
- K941258: Latex Condom (1995), cited by 3
- K030176: Lifestyles, Contempo or Private Label-Male Latex Condom with Desensitizing Lubricant (2003), cited by 1
- K010371: Lifestyles, Contempo or Private Label, Male Latex Condom with Glycerine Lubricant (2001), cited by 1
- K910284: Condoms (Rubber Contraceptives) (1991), cited by 1

## Recent decisions
- 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)

Source page: https://510kreport.com/company/suretex