Polyisoprene surgical glove, non-powdered - ARTG 473588
Access comprehensive regulatory information for Polyisoprene 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 473588 and sponsored by Mediflex Industries Pty Ltd, manufactured by PT Medisafe Technologies in Indonesia. The device registration started on December 17, 2024.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
A sterile device made of polyisoprene 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. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. 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.