Pure Global

Nitrile examination/treatment glove, non-powdered - ARTG 412974

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 412974 and sponsored by Reynard Health Supplies (Aus) Pty Ltd, manufactured by Anhui Intco Medical Products Co Ltd in China. 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 412974
Class I
Nitrile examination/treatment glove, non-powdered
ARTG ID: 412974
Good Name: Reynard Health Supplies (Aus) Pty Ltd - Nitrile examination/treatment glove, non-powdered
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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
ARTG ID
412974
Start Date
July 07, 2023
Effective Date
July 07, 2023
Manufacturer
Country
China
Address
No 6 Haitang South Road Suixi Wuhu Modern Industrial Park, Suixi County, Huaibei City, Anhui Province, 235100