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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 Pacsource Pty Ltd, manufactured by Shandong INTCO Medical Products Co Ltd in China. The device registration started on July 09, 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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TGA ARTG Official Data
Class I
Class I
Nitrile examination/treatment glove, non-powdered
Australia TGA ARTG Registered Device
Good Name: Pacsource Pty Ltd - Nitrile examination/treatment glove, non-powdered
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Intended Purpose

Nitrile powder free examination glove is intended for medical purposes such as conducting medical examination, diagnostic and therapeutic procedures that is worn on the examiner's hand to prevent contamination between the examiner and patient. They are not intended as a substitute for surgeon's gloves for surgical work. The medical device is intended for single use.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 09, 2024
Effective Date
July 09, 2024
Manufacturer
Country
China
Address
No 9888 Qiwang Road Naoshan Industrial Park, Qingzhou, Shandong, 262500