Supermax Corporation Berhad
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Our Business: Quality Assurance
 Quality Management System Awarded to Supermax
ISO 9001:2000 SIRIM, Malaysia
Special Regulation NF101 AFNOR, LNE, France
Certificate of Good Manufacturing Practice of Medical Devices Manufacturer by Anvisa, Brasil
ISO 9001:2000 BVQI
CE Mark on Sterilised Latex Gloves audited by SGS, UK and SGS, Malaysia
ISO 13485: 2003 audited by Standard Council of Canada, accredited registrar, SGS Canada
Accreditation Certificate of Foreign Medical Device Manufacturer by Ministry of Health, Labour and Welfare Japan
 FDA 510K Certification
FDA 510k registration
With US FDA on Low Powder Hypoallergenic Latex Examination Gloves
FDA 510k registration
With US FDA on Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 mgs or less)
FDA 510k registration
With US FDA on Latex Powdered Exam Gloves with 70 mgs or Less Total Water Extractable Protein Per Gram.
FDA 510k registration
With US FDA on Polymer Coated Powder Free Latex Examination Gloves(50 mgs or less protein labeling claim)
FDA 510k registration
With US FDA on Powdered Nitrile Examination Gloves
FDA 510k registration
With US FDA on Aurelia Chlorinated Powder Free Latex Medical Examination gloves with Aloe Vera & Ginseng with Protein Labeling Claim (50 mgs or less)
FDA 510k registration
With US FDA on Powder Free Nitrile Examination Gloves
FDA 510k registration
With US FDA on Green Peppermint Flavored Powdered Latex Examination Gloves
FDA 510k registration
With US FDA on Green Peppermint Flavored Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 mgs or less)
FDA 510k registration
With US FDA on Sterile Powdered Latex Examination Gloves
FDA 510k registration
With US FDA on Sterile Powdered Latex Surgeon Gloves
FDA 510k registration
With US FDA on Sterile Powder Free Latex Surgeon gloves with Protein Labeling claim (50 mgs or less)
FDA 510k registration
With US FDA on Green Powder Free Nitrile Medical Examination Gloves with Peppermint Flavour.
 Product Certification
Certificate of Listing from Canadian General Standards Board (CGSB), Canada
Certificate of Listing No: AUST L 63625 from TGA, Australia
Authorization for the Use of Conformity Identification Seal from OCP, Brasil
Standard Malaysian Glove Certificate of Accreditation from Malaysian Rubber Board
Directive 93/42/EEC Annex V (Sterility only) Sterile Gloves from SGS, UK
Directive 89/686/EEC Article 11B-PPE from SGS, UK
 Test Conduct on Gloves
Watertightness : ASTM D5151:99
Physical Properties :
1) Dimension : ASTM D3767:01
2) Tensile : ASTM D412:98 & ASTM D573:99
Protein Testing : ASTM D5712:99
Residual Powder Testing : ASTM D6124:01
Biocompatibility Testing
*Samples sent to CPTC, USA for testing
Bioburden Testing
*Samples sent to microbiological lab for testing
 Quality Policy

As a leading medical glove manufacturer, Supermax Glove Manufacturing Sdn Bhd shall be

Committed to:-

Produce gloves to attain customer satisfaction and to meet the requirements of customer 


and international glove standards.

Promote teamwork and employee satisfaction to ensure a conducive work environment. 

Undertake continual improvement in quality system activities.
Meeting expectation and requirement of interested parties.