Hevea-latex examination/treatment glove, powdered
Access comprehensive regulatory information for Hevea-latex examination/treatment glove, powdered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Ultra Health Medical Pty Ltd, manufactured by Sri Trang Gloves (Thailand) Public Company Limited in Thailand. The device registration started on October 23, 2023.
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A non-sterile device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is covered with talcum powder to facilitate donning/removal. The device is used mainly as a two-way barrier to protect both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility and comfort of use, and should provide 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.