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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 Niagara Australia Pty Ltd, manufactured by MEGINE INDUSTRIES SDN BHD in Malaysia. The device registration started on May 25, 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: Niagara Australia Pty Ltd - Nitrile examination/treatment glove, non-powdered
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Intended Purpose

Intended to be worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 25, 2020
Effective Date
May 25, 2020
Sponsor
Manufacturer
Country
Malaysia
Address
B-05-02 The Vertical Business Suites No 8 Jalan Kerinhi, Bangsar South, Kuala Lumpar, 59200