Hevea-latex surgical glove, non-powdered - ARTG 341020
Access comprehensive regulatory information for Hevea-latex surgical glove, non-powdered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 341020 and sponsored by Ultra Health Medical Pty Ltd, manufactured by TG Medical Sdn Bhd in Malaysia. The device registration started on August 06, 2020.
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A sterile device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.