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Vinyl examination/treatment glove, non-powdered - ARTG 446730

Access comprehensive regulatory information for Vinyl 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 446730 and sponsored by Ultra Health Medical Pty Ltd, manufactured by Blue Sail Medical Co Ltd in China. The device registration started on April 26, 2024.

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
ARTG 446730
Class I
Vinyl examination/treatment glove, non-powdered
ARTG ID: 446730
Good Name: Ultra Health Medical Pty Ltd - Vinyl examination/treatment glove, non-powdered
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Intended Purpose

A non-sterile device made of vinyl 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. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
446730
Start Date
April 26, 2024
Effective Date
April 26, 2024
Manufacturer
Country
China
Address
Qilu Chemical Industrial Park No 21 Qingtian Rd, Zibo, Shandong, 255414