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OTHERS AT SYSTEMATIZATION BERHAD ("ATS" OR THE "COMPANY") REGISTRATION OF AT GLOVE ENGINEERING SDN. BHD. A WHOLLY OWNED SUBSIDIARY OF THE COMPANY WITH THE U.S. FOOD AND DRUG ADMINISTRATION

AT SYSTEMATIZATION BERHAD

Type Announcement
Subject OTHERS
Description
AT SYSTEMATIZATION BERHAD ("ATS" OR THE "COMPANY")
REGISTRATION OF AT GLOVE ENGINEERING SDN. BHD. A WHOLLY OWNED SUBSIDIARY OF THE COMPANY WITH THE U.S. FOOD AND DRUG ADMINISTRATION

The Board of Directors of AT Systematization Berhad (“ATS” or the “Company”) is pleased to inform that AT Glove Engineering Sdn. Bhd. (“AGESB”), a wholly owned subsidiary of the Company had on 1 February 2021 received the establishment registration with the Food and Drug Administration of the United States (“FDA”).

The disposable gloves are classified as medical devices and are subject to full FDA certification before it can be sold, to ensure the safety and effectiveness of the gloves. Pursuant to a guidance issued by the FDA in March 2020, in view of the ongoing COVID-19 pandemic, the FDA does not object the distribution and use of gloves which has yet to comply with the regulatory requirements for full FDA certification, provided that the gloves are labelled in accordance with the guidelines issued by the FDA.

Following the receipt of establishment registration with FDA, AGESB can now export its medical examination gloves to the United States.

This announcement is dated 5 February 2021.






Announcement Info

Company Name AT SYSTEMATIZATION BERHAD
Stock Name AT
Date Announced 05 Feb 2021
Category General Announcement for PLC
Reference Number GA1-04022021-00065




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