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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 Reynard Health Supplies (Aus) Pty Ltd, manufactured by Comfort Rubber Gloves Industries Sdn Bhd in Malaysia. The device registration started on July 07, 2023.

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: Reynard Health Supplies (Aus) Pty Ltd - Nitrile examination/treatment glove, non-powdered
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Intended Purpose

A single-use, non-sterile device made of nitrile, intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment, or for other sanitary purposes. Its inner surface is not covered with talcum powder, and the device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 07, 2023
Effective Date
July 07, 2023
Manufacturer
Country
Malaysia
Address
Lot 821 & 2209 Jalan Matang, 34750 Matang Taiping , Perak Darul Ridzuan,