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2022-6-15 · FDA Registration - Latex and Nitrile gloves. FDA regulates latex and nitrile gloves (examination and surgical) as medical devices. Even though the gloves are class 1 device, it requires FDA 510K Clearance, Medical device establishment registration, and device listing to market in the USA. Powdered gloves are not allowed to market in the USA for ...
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2021-11-8 · Registration requirements for medical devices in Vietnam are currently in a state of transition. New rules governing the registration of medical devices were published on November 8, 2021 with Decree No. 98/2021. This new Decree overrules previous Decree No. 36/2016/ND-CP as amended with Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP.
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The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unnotified medical device product: “NITRILE DISPOSABLE GLOVES POWDER-FREE, NON-STERILE” The FDA verified […]
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