Australia TGA ARTG record

Nitrile examination/treatment glove, non-powdered

Australia TGA ARTG Registered Device · Tiny Hearts Pty Ltd · Blue Sail Medical Co Ltd · Class I · Started November 29, 2022

Good Name: Tiny Hearts Pty Ltd - Nitrile examination/treatment glove, non-powdered

Device classification

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

Registration information

Start Date: November 29, 2022
Effective Date: November 29, 2022

Sponsor

Name: Tiny Hearts Pty Ltd

Manufacturer

Name: Blue Sail Medical Co Ltd
Country: China
Address: No 21 Qingtian Road Qilu Chemical Industrial Park, Zibo, Shandong, 255414

Intended purpose

A non-sterile nitrile glove intended for use as a protective barrier.

About this record

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 Tiny Hearts Pty Ltd, manufactured by Blue Sail Medical Co Ltd in China. The device registration started on November 29, 2022.

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.