Презервативы ROTEX ® (Manufactured under USA patents)
All ROTEX ® condoms are manufactured according to ISO4074, ASTM D3492 and latest WHO specifications. We choose the quality natural latex and add into the qualified vulcanization, promoter, ageing-resistant. Through the process of beforehand vulcanization, shaping and back vulcanization. All the products are tested by the electronic. After passed the test of pinhole leakage, mechanic and air burst, the products can be packaged in airtight condition. The testing results of condoms conform to ASTM D3492, EN600, WHO GPA/TCO/PRV, GB7544. Since 1997 we joined the laboratory comparable rest organized by Australia ENERSOL Consulting Engineers (phone:+61 2 9552 1707). The result identify that the inspection level achieve the international level.
All ROTEX ® condoms have been tested in conformance with the following test methods of ISO10993 Biological Evaluation of Medical Devices of ODE Guidance Memorandum G95-1 dated May 1, 1995, for a Device in Contact for 24hours or less with Skin/ Mucosal Membrane Surface. When evaluated according to this standard, the condom is not toxic (local or Systemic), sensitizing, locally irritating or otherwise harmful.
* ISO10993-5 ---- Cytotoxicity
* ISO10993-10---- Irritation and Sensitization
* ISO10993-11 ---- Systemic Toxicity
* ISO10993-12 ---- Sample Preparation and Reference Materials