AT Systematization Nitrile Gloves Receives US FDA Approval

AT Systematization Berhad through its wholly-owned subsidiary, AT Glove Engineering Sdn. Bhd announced that the Company will now be able to proceed with marketing activities of its nitrile gloves in the U.S. after meeting the U.S. Food and Drug Administration’s procedural requirements.

The Company recently received notification letter from the United States (US) Food and Drug Administration in relation to the 510(k) premarket notification clearance, which provides for the potential to ship and market the nitrile examination gloves into the U.S. 

Choong Lee Aun, Managing Director of AT said, “The FDA 510(k) Medical Product License clearance allows us to expand our product reach to a broader market into the highly lucrative U.S. market. It is part of our efforts to expand the Company’s geographical reach”.

“These moves to expand to the U.S. markets will also be supporting the take-up of additional production capacity coming onstream. There will be adding four lines to be commissioned soon at our factory located at Chemor, Perak, which will boost our production capacity to 2.0 billion per year”.

AT entered into produce medical-grade nitrile examination gloves in 2020 is currently running 6 production lines with an annual capacity of 1.2 billion at the factory located at Chemor, Perak.

Aside from the additional four lines to be commissioned soon, which will boost the Company’s production capacity to 2.0 billion per year, AT is also aggressively ramping up capacity expansion for the glove division to capture more business and recently completed the acquisition of several industrial plots in Kamunting, Perak to cater for more than 50 production lines that will boost its annual production capacity.

Choong added that the demand for gloves is expected to continue to rise due to better healthcare awareness, especially from the emerging economies.

“There is increasing usage of gloves in more sectors and industries as part of the new normal, including airlines, hospitality, and the food processing sector. The rising need for quality medical gloves will continue to sustain the global demand for gloves in the long run”.

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