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Nitrile examination/treatment glove, non-powdered

Access comprehensive regulatory information for Nitrile examination/treatment glove, non-powdered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by GH Supplies Pty Ltd, manufactured by PT Universal Gloves in Indonesia. The device registration started on March 27, 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.

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TGA ARTG Official Data
Class I
Class I
Nitrile examination/treatment glove, non-powdered
Australia TGA ARTG Registered Device
Good Name: GH Supplies Pty Ltd - Nitrile examination/treatment glove, non-powdered
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Intended Purpose

A non-sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. This is a single-use device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 27, 2020
Effective Date
March 27, 2020
Manufacturer
Country
Indonesia
Address
JIn Pertahanan No17 Patumbak Kampung, Deli Serdang, Sumatera Utara, 20361