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AT Glove Gets FDA’s 510(k) Clearance for its Nitrile Gloves

January 6, 2022

Medical glove manufacturer AT Glove Engineering has received the FDA’s 510(k) clearance for its nitrile medical gloves.

The Malaysian glovemaker, a subsidiary of Kuala Lumpur-based AT Systematization, said it plans to boost its production capacity to 2 billion pieces annually.

The FDA issued a draft rule in January 2021 proposing that seven types of medical gloves classified as “reserved” Class I devices would not need 510(k) clearances. But the agency later reversed that policy in an April 16 final rule. Class I devices are generally considered low-risk and do not require 510(k) clearance.

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