American Standards

Natural Rubber Latex Gloves:

ASTM D3578

Standard Specification for Rubber Exam Glove

License of Medical Devices from Ministry of Health of the Republic of INDONESIA (KEMENKES Registration and Distribution Approval).

We also comply to the following Quality Management Regulations:

  • ISO 9001
  • FDA Quality System Regulations

European Standards

EN 455-1

Medical Gloves for Single Use – Part 1: Requirements and testing for freedom from holes

EN 455-2

Medical Gloves for Single Use – Part 1: Requirements and testing for freedom from holes

EN 455-3

Medical Gloves for Single use – Part 3: Requirements and testing for Biological Evaluation

EN 455-4

Medical Gloves for Single use – Part 2: Requirements and testing for shelf life determination

EN 374

Protective gloves against chemicals and micro-organisms-