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Mah Sing Healthcare obtains CE mark, ready to export to Europe


Confirmed glove orders produced by Mah Sing Healthcare, ready to be shipped to customers.

3 JUNE, KUALA LUMPUR – Mah Sing Healthcare Sdn Bhd (Mah Sing Healthcare) has received the Conformitè Europëenne (CE) Mark for powder free nitrile examination gloves and powder free latex examination gloves, which would facilitate the company to tap into the export market to the European region. The CE mark is recognised by EU member states that the product meets all appropriate EU requirements including relevant European product directive, harmonised performance and safety standards, and is fit for its purpose and will not endanger lives or property.

Concurrently, Mah Sing Healthcare also obtained the certificate issued by TÜV Rheinland LGA Products GmbH certifying that the company has established and applies a Quality Management System for Medical Devices, and is in compliance with EN ISO 13485:2016 standard for the manufacturing and distribution of Natural Rubber (NR) Latex Examination Gloves Powder Free, Non-sterile and Nitrile Butadiene Rubber (NBR) Examination Gloves Powder Free, Non-sterile.

TÜV Rheinland is one of the world’s leading testing service providers, with nearly 150 years of experience. As an independent third party, TÜV Rheinland tests technical systems, products and services, supports projects and tests processes for companies and organisations. The EN ISO 13485:2016 certification reflects Mah Sing’s commitment to enforce a strong quality management system during the production of gloves in the factory, benchmarking against the global standard.

Mah Sing’s Founder and Group Managing Director, Tan Sri Dato’ Sri Leong Hoy Kum said, “We are meeting new milestones and is a serious, long-term player for the glove business. With the CE certification, we are ready for export to Europe. Mah Sing remains committed in adhering to the relevant authorities and complying with the highest standards set by the industry, which are safe for local and export consumption. This marks a step forward for us in meeting the global demand of gloves with the production of quality products.”

Mah Sing Healthcare has commenced operation at its first glove manufacturing factory in Kapar Klang, with the first shipment of gloves delivered in May/June 2021. Prior to this, Mah Sing Healthcare has obtained 2 FDA Establishment Licenses for Polymer Nitrile Patient Examination Glove and Latex Patient Examination Glove from the US Food & Drug Administration (FDA), which all glove manufacturers are required to register in order to sell gloves in the US. It is also progressing well in obtaining FDA 510(k) Premarket Notification for export to the US market. In addition, Mah Sing Healthcare has also received the export license from the Malaysian Rubber Board, which would facilitate the export business for the Group’s glove manufacturing operation.

READ: Confirmed glove orders produced by Mah Sing Healthcare, ready to be shipped to customers.

Looking ahead, the Group expects structural increase in glove usage as a result of new norms, fears of re-infection, higher health awareness and hygiene compliance requirements for healthcare and non-healthcare sectors, and this will continue to support strong demand for the gloves post-pandemic.

Currently, execution of the glove venture is on schedule as there will be six production lines on track to be operational in 2Q2021, followed by another six production lines in 3Q2021. By then, the highly automated Kapar factory will have a maximum production capacity of up to 3.68 billion pieces of gloves per annum. These 12 units of new, high speed glove dipping machines – producing at a speed of 38,000 pieces of gloves per production line per hour are under Phase 1 of Mah Sing’s glove manufacturing business.

Mah Sing Healthcare is a wholly owned subsidiary of Mah Sing Plastics Industries Sdn Bhd, which in turn is a wholly owned subsidiary of Mah Sing Group Berhad.

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