Supermax

AS A LEADING MEDICAL GLOVE MANUFACTURER,

The Supermax Group is commited to:

Producing gloves that attain customer satisfaction and that meet the requirements of customers, applicable regulatory bodies and established glove standards
Promoting teamwork and employee satisfaction to ensure a conducive work environment
Maintaining the effectiveness of its Quality Management Systems and undertake continual improvement in quality system activities.
Meeting the expectations and requirements of interested parties.

Certification

FDA 510k Registration

*US Food & Drug Administration

Standard Malaysian Glove (SMG)

*Malaysian Rubber Board, Malaysia

Europe CE 1639 Mark Directive 93/42/EEC

*SGS Belgium NV

Europe CE 0598 Mark Regulation (EU) 2016/425

*SGS Fimko Oy

National Health Surveillance Agency (ANVISA), Brazil

*RDC nº 55/2011

Medical Device Licence, Canada

*Medical Device Bureau, Health Canada

Quality Management System ISO 9001: 2015

*SGS United Kingdom Ltd

Quality Management System ISO 13485: 2016

*SGS (Malaysia) Sdn Bhd

Quality Management System ISO 9001: 2015

*SIRIM QAS International Sdn Bhd, Malaysia

Quality Management System ISO 9001: 2015

*TUV SUD America Inc

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 9001:2015 certified by SGS, UK

CE Mark on Sterilised Latex Gloves certified by SGS, Belgium

ISO 13485:2016, EN ISO 13485:2016 certified by SGS,UK

ISO 13485:2016 certified by SGS, Malaysia

MDSAP certified by TÜV SÜD, America

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

Australian Register of Therapeutic Goods (ARTG)

Directive 93/42/EEC Annex V (Sterility only) Sterile Gloves from SGS, Belgium

Authorization for the Use of Conformity Identification Seal from OCP, Brasil

Regulation (EU) 2016/425 from SGS, Finland

Standard Malaysian Glove Certificate of Accreditation from Malaysian Rubber Board

Regulation (EU)2016/245 as brought into UK Law and amended from SGS,UK

Test Conduct on Gloves

Watertightness : ASTM D5151, EN455-1

Physical Properties :
1) Dimension : ASTM D3767, EN455-2
2) Tensile : ASTM D412 & ASTM D573, EN455-2

Protein Testing : ASTM D5712, EN455-3

Residual Powder Testing : ASTM D6124, EN455-3

Biocompatibility 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.

CONTACT LENSES

The Supermax Group is committed to:

Producing contact lenses that ensure customer satisfaction, meeting customer requirements, applicable regulatory standards, and industry guidelines.
Promoting teamwork and employee satisfaction to foster a positive and productive work environment.
Maintaining the effectiveness of the Quality Management System and pursuing continuous improvement in quality system activities.
Meeting the expectations and requirements of all interested parties.

Contact Lenses Quality Assurance

ISO 9001:2015

Malaysia

TUV-SUD

EN ISO 13485:2016

Malaysia

TUV-SUD

MDR CE Certificate

Malaysia

TUV-SUD

ISO 13485:2016 MDSAP

Malaysia

TUV-SUD

MDA Establishment License

Malaysia

(MDA)

Medical Device Authority

MDA Product Registration Certificate

Malaysia

(MDA)

Medical Device Authority

USA FDA 510K (K180985)

USA

(FDA)

Food and Drug Administration

US FDA 510K (K162223)

USA

(FDA)

Food and Drug Administration

China NMPA Product Certificate

China

(NMPA)

National Medical Products Administration

Brasil ANVISA Product Registration Certificate

Brasil

Anvisa

Health Canada Medical Device License

Canada

Health Canada

Japan MHLW Registration Certificate

Japan

(MHLW)

Ministry of Health,

Labour and Welfare

Japan PMDA Product Registration Certificate

Japan

(MHLW)

Ministry of Health,

Labour and Welfare

Singapore HSA Product Registration Certificate

Singapore

(HSA)

Health Sciences Authority

Korea GMP Certificate

Korea

(MFDS)

Ministry of Food and Drug Safety

Korea MFDS Product Registration Certificate

Korea

(MFDS)

Ministry of Food and Drug Safety

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