Australia TGA ARTG recordHevea-latex surgical glove, non-powdered
Australia TGA ARTG Registered Device · Ultra Health Medical Pty Ltd · TG Medical Sdn Bhd · Class IIa · Started August 06, 2020
Good Name: Ultra Health Medical Pty Ltd - Hevea-latex surgical glove, non-powdered
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- August 06, 2020
- Effective Date
- August 06, 2020
- Country
- Malaysia
- Address
- Lot 5091 Jalan Teratai Batu 5 off Jalan Meru, Klang, Selangor Darul Ehsan, 41050
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.
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 sponsored by Ultra Health Medical Pty Ltd, manufactured by TG Medical Sdn Bhd in Malaysia. The device registration started on August 06, 2020.
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.