Manufacturing Condoms
LTC Healthcare’s condom products all comply with current European and UK legislation. LTC Healthcare manufactures all of its condoms to the requirements of ISO4074:2002.
Our factories are also licensed to manufacture condoms to the following standards:-
• ISO 9001:2000
• ISO 13485:2003
• Medical Devices Directive 93/42/EEC CE0499
• China Compulsory Certification (CCC)
• USFDA 21 CFR Part 820 Quality Systems
• BSI Kitemark Certification
LTC Healthcare has recently introduced its own quality standard which requires our factories to test twice as many products as would normally be required by standard BSI testing.
This testing is also done to a greater degree than normally required for BSI testing. For example, the international standard for the air burst test is currently 18litres of air, but LTC Healthcare requires the factory to test for air burst to at least 22litres of air. Typically, ‘EXSTM’, ‘Boys OwnTM’ and ‘Girls OwnTM’ condoms will expand to pressures in excess of 35litres of air.
Current trends in condom manufacture are for extensive and rigorous washing of the latex products. This reduces the levels of proteins and allergens present in the finished product.
