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 13485 : 2016 Management System
- FDA Quality System Regulations
- HALAL Management System
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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-