Pure Global

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 FPA Australia Pty Ltd, manufactured by Jiangsu Jaysun Glove Co Ltd in China. The device registration started on October 01, 2015.

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: FPA Australia Pty Ltd - Nitrile examination/treatment glove, non-powdered
Pure Global
DJ Fang

DJ Fang

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Intended Purpose

Nitrile gloves are made out of a synthetic rubber, and are an ideal alternative when latex allergies are of concern. Nitrile gloves are the superior glove when it comes to puncture resistance. Nitrile gloves are often referred to as โ€œmedical grade.โ€ Nitrile examination gloves are suitable in work environments where there is possible contact with bodily fluids, microorganisms, and chemicals. Our powder-free gloves offer high flexibility, tactility, tear and chemical resistance. Nitrile gloves have been tested for use with Chemotherapy drugs.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 01, 2015
Effective Date
October 01, 2015
Manufacturer
Country
China
Address
199 Jianling Road Economic Developing-Area, Siqian City, Jiangsu Province