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Polyisoprene surgical glove, non-powdered - ARTG 449588

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 449588 and sponsored by Pluspak Safety Pty Ltd, manufactured by Guilin HBM Health Protections Inc in China. The device registration started on May 24, 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.

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Class IIa
ARTG 449588
Class IIa
Polyisoprene surgical glove, non-powdered
ARTG ID: 449588
Good Name: Pluspak Safety Pty Ltd - Polyisoprene surgical glove, non-powdered
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DJ Fang

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Intended Purpose

Surgical Polyisoprene gloves are designed to provide healthcare professionals with a reliable barrier against biological and chemical hazards during Surgical procedures. These gloves are suitable for wide range of surgical procedures.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
449588
Start Date
May 24, 2024
Effective Date
May 24, 2024
Manufacturer
Country
China
Address
No 1-2 Shuijing East Road Economic and Technological Development Area, Guilin