Certifications

Certifications

Rich Quality Leadership in Malaysia

Throughout our operations, we have led the Malaysian disposable glove industry with our quality accomplishments, achieving the highest level of compliance with the world’s most respected quality organizations as well as regulatory clearances for the sale of medical devices in the United States and Europe, among other countries.

In our pursuit for excellence and setting new standards for the global glove industry, Medrux has demonstrated world-class standards for Environmental Management System, Occupational Health and Safety, Business and Social Compliance and Compliance to Product Safety.

Medrux has received numerous internationally recognized quality certifications and are proud to achieve ISO 13485 certifications.

The quality model for the global medical device industry that specifically addresses the unique quality and safety requirements of medical devices in addition to the basic requirements of ISO 9001.

Regulatory Clearances

Our gloves meet or exceed the requirements of the Europe’s Medical Device Directives MDD 93/42/EEC and CE marking. . (Please check our certifications here)

Certifications for Certain Regions:

Our Product: LATEX POWDER FREE is SFDA approved (Check SFDA website here to verify)

SFDA approved latex gloves Saudi Arabia

 

International Testing Standards

We comply with these additional international standards:

  • International / Europe:  EN 455

EN 455-1: Testing for Freedom from Holes

EN 455-2: Testing for Physical Properties

EN 455-3: Testing for Biological Evaluation: Endotoxin

  • United States: ASTM D3577 / D3578 / D5712  / D6124

 

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