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Nitrile surgical glove, non-powdered

Access comprehensive regulatory information for Nitrile surgical glove, non-powdered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Omni-Tel Pty Ltd, manufactured by Top Glove Sdn Bhd in Malaysia. The device registration started on September 06, 2019.

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
Class IIa
Nitrile surgical glove, non-powdered
Australia TGA ARTG Registered Device
Good Name: Omni-Tel Pty Ltd - Nitrile surgical glove, non-powdered
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Intended Purpose

To provide a protective barrier between the users hands and the surrounding. Protects from spills, splashes and airborne particles in a surgical environment.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 06, 2019
Effective Date
September 06, 2019
Sponsor
Manufacturer
Country
Malaysia
Address
Lot 4969 Jalan Teratai Batu 6 off Jalan Meru, Klang, Selangor DE, 41050