Australia TGA ARTG record

Nitrile surgical glove, non-powdered

Australia TGA ARTG Registered Device · Omni-Tel Pty Ltd · Top Glove Sdn Bhd · Class IIa · Started September 06, 2019

Good Name: Omni-Tel Pty Ltd - Nitrile surgical glove, non-powdered

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

Name: Omni-Tel Pty Ltd

Manufacturer

Name: Top Glove Sdn Bhd
Country: Malaysia
Address: Lot 4969 Jalan Teratai Batu 6 off Jalan Meru, Klang, Selangor DE, 41050

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.

About this record

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.