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Nitrile examination/treatment glove, non-powdered - ARTG 439970

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 registered under ARTG number 439970 and sponsored by EMKA Australia Pty Ltd, manufactured by Maxter Glove Manufacturing Sdn Bhd in Malaysia. The device registration started on February 06, 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
ARTG 439970
Class I
Nitrile examination/treatment glove, non-powdered
ARTG ID: 439970
Good Name: EMKA Australia Pty Ltd - Nitrile examination/treatment glove, non-powdered
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Intended Purpose

Intended use of the non-sterile examination glove is to be worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
439970
Start Date
February 06, 2024
Effective Date
February 06, 2024
Manufacturer
Country
Malaysia
Address
Lot 6070 Jalan Haji Abdul Manan, 6th Miles off Jalan Meru / 41050 Klang, Selangor Darul Ehsan