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.
