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Polychloroprene surgical glove, non-powdered - ARTG 475291

Access comprehensive regulatory information for Polychloroprene 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 475291 and sponsored by The Glove Company Pty Ltd, manufactured by PT Medisafe Technologies in Indonesia. The device registration started on January 08, 2025.

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 475291
Class IIa
Polychloroprene surgical glove, non-powdered
ARTG ID: 475291
Good Name: The Glove Company Pty Ltd - Polychloroprene surgical glove, non-powdered
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Intended Purpose

It is intended to be used once in an invasive procedure involving a single patient and permanently discarded after use. These gloves are worn on the hands of healthcare personnel to provide barrier protection from cross-contamination between patients and healthcare personnel. The healthcare personnel includes surgeons and operation theatre staff. This device is not a measuring device, not used for screening, monitoring, diagnosing, prognosing, prediction or companion diagnostic devices. This medical device is not intended to identify a disorder or define and differentiate it. This medical device is not an automated, qualitative or quantitative device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
475291
Start Date
January 08, 2025
Effective Date
January 08, 2025
Manufacturer
Country
Indonesia
Address
Jl Batang Kuis gg Tambak Rejo/Pasar IX Desa Buntu Bedimbar Tanjung Morawa, Medan, Sumatera Utara, 20362