Suretex Limited Thailand kondomproducent

Suretex Limited er en af ​​kondomfabrikkerne i Thailand. Det er fuldt ejet af Lifestyle, og de har to fuldt ejede produktionsfaciliteter, en i Thailand, en anden i Indien.
Adresse: 31/1 Moo 4, Suratthani-Thakuapha Road
Tambon Khao Hua Kwai, Amphur Phunphin
Suratthani 84130 THAILAND

Device Name:
Handelsnavn: LifeStyles® NRL Textured Condom
Common Name: Naturgummi latex kondom til mænd
Regulation Name: Condom
Regulation Number: 21 CFR 884.5300
Device Class: Class II
Product Code: HIS (Condom)

Predicate Device Information:
Handelsnavn: FAMA Male Latex Condoms
510K Number: K220576
Manufacturer: Shanghai Personage Hygiene Products Co. Ltd
Common Name: Naturgummi latex kondom til mænd
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.