Pure Global

Gown, isolation, single use

Access comprehensive regulatory information for Gown, isolation, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Envirofluid, manufactured by Leboo Healthcare Products Ltd in China. The device registration started on April 04, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
Class I
Gown, isolation, single use
Australia TGA ARTG Registered Device
Good Name: Envirofluid - Gown, isolation, single use
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

A garment intended to be worn by Healthcare providers or visitors to isolate themselves from patients. This isolation gown also helps the patient from the transfer of infectious agents by the Healthcare provider or the visitor. It also helps to protect the Healthcare Provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 04, 2022
Effective Date
April 04, 2022
Sponsor
Manufacturer
Country
China
Address
A-1506 Lar Valley International No 168 Guang'anmen Wai Street, Xicheng District, Beijing, 100055