Quality Management System Awarded to Supermax
|
|
 |
|
ISO 9001:2015 certified by SIRIM, Malaysia
|
|
|
|
|
|
Certificate of Good Manufacturing Practice of Medical Devices Manufacturer certified by Anvisa, Brasil |
|
|
|
|
ISO 9001:2000 certified by SGS, UK |
|
|
|
|
CE Mark on Sterilised Latex Gloves certified by SGS,UK |
|
|
|
|
ISO 13485: 2003 CMDCAS certified by SGS,UK |
|
|
|
|
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 , |
|
|
|
applicable regulatory requirements and glove standards |
|
|
|
Promote teamwork and employee satisfaction to ensure a conducive work environment. |
|
|
|
|
Maintain the effectiveness of Quality Management System and undertake continual |
|
|
|
improvement in quality system activities.
|
|
|
|
|
Meeting expectation and requirement of interested parties. |
|
