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Hevea-latex surgical glove, non-powdered - ARTG 430854

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 430854 and sponsored by Touch Biotechnology Pty Ltd, manufactured by Supermax Glove Manufacturing Sdn Bhd in Malaysia. The device registration started on December 14, 2023.

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.

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TGA ARTG Official Data
Class IIa
ARTG 430854
Class IIa
Hevea-latex surgical glove, non-powdered
ARTG ID: 430854
Good Name: Touch Biotechnology Pty Ltd - Hevea-latex surgical glove, non-powdered
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Intended Purpose

Intended as a protective barrier when worn on the hands of healthcare providers at the surgical site. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. This is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
430854
Start Date
December 14, 2023
Effective Date
December 14, 2023
Manufacturer
Country
Malaysia
Address
Lot 42 Putra Industrial Park Bukit Rahman Putra, Sungai Buloh, Selangor Darul Ehsan, 47000