Amazing Glove
Our Quality
Our commitment to quality starts at the very beginning. From the time we begin sourcing our materials to the delivery of our end product, we’ve ensured the most stringent quality control procedures are implemented by our highly-trained staff.
Strict quality guidelines are applied to our internal SOPs in order to deliver world-class products that adhere to international standards.
Below are the International Standards that our products comply to :
American Standards
Natural Rubber Latex Gloves:
- ASTM D3578 – Standard Specification for Rubber Exam Glove
Nitrile Gloves:
- ASTM D6319 – Standard Specification for Nitrile Examination Gloves for Medical Application
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 2: Requirements and testing for physical properties
- 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-
Part 2 – Determination or resistance to penetration
Part 3 – Determination of resistance to permeation by chemicals
We also comply to the following Quality Management Regulations:
- ISO 9001: 2008
- ISO 13485: 2003
- FDA Quality System Regulations
- 21CFR 820: Code of Federal Regulations (820-Medical Device)
- EC Directive 93/42/EEC amended by 2007/47EC
