Australia TGA ARTG record

Nitrile examination/treatment glove, non-powdered, antimicrobial

Australia TGA ARTG Registered Device · Big Start Pty Ltd · GAUKE Healthcare Co Ltd · Class I · Started March 05, 2021

Good Name: Big Start Pty Ltd - Nitrile examination/treatment glove, non-powdered, antimicrobial

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: March 05, 2021
Effective Date: March 05, 2021

Sponsor

Name: Big Start Pty Ltd

Manufacturer

Name: GAUKE Healthcare Co Ltd
Country: China
Address: Chengnan Industrial Park TuanFeng County, Huang Gang, Hubei, 438800

Intended purpose

Protective barrier when worn on the hands of healthcare providers during patient examination or treatment. Nitrile material with non-powdered inner surface

About this record

Access comprehensive regulatory information for Nitrile examination/treatment glove, non-powdered, antimicrobial in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Big Start Pty Ltd, manufactured by GAUKE Healthcare Co Ltd in China. The device registration started on March 05, 2021.

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.