Fabricante de preservativos Suretex Limited na Tailândia

Suretex Limited é uma das fábricas de preservativos localizadas na Tailândia. É propriedade integral da Lifestyle, e eles têm duas fábricas próprias, um na Tailândia, outro na Índia.
Endereço: 31/1 Mu 4, Suratthani-Thakuapha Road
Tambon Khao Hua Kwai, Amphur Phunphin
Suratthani 84130 THAILAND

Device Name:
Nome comercial: LifeStyles® NRL Textured Condom
Common Name: Preservativo masculino de látex de borracha natural
Regulation Name: Condom
Regulation Number: 21 CFR 884.5300
Device Class: Class II
Product Code: HIS (Condom)

Predicate Device Information:
Nome comercial: FAMA Male Latex Condoms
510K Number: K220576
Manufacturer: Shanghai Personage Hygiene Products Co. Ltda
Common Name: Preservativo masculino de látex de borracha natural
Regulation Name: Condom
Regulation Number: 21 CFR 884.5300
Device Class: Class II
Product Code: HIS (Condom)

The NRL Textured Condom has a five-year shelf life based on the results
of accelerated stability evaluations conducted as required in 21 CFR 801.435. All
samples met predefined acceptance criteria.

Conclusion
The results of performance testing demonstrate that the NRL Textured
Condom is as safe and effective as the predicate device and supports a determination
of substantial equivalence.

As an FDA 510k approved condom plant, Welcome worldwide clients inquiry us to custom make your own branded condoms, we are pleasure to custom work for you.