Pure Global

Gown, operating room, single use - ARTG 467571

Access comprehensive regulatory information for Gown, operating room, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 467571 and sponsored by Wiselink Group Pty Ltd, manufactured by Cobes Industries Hefei Co Ltd in China. The device registration started on November 07, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class Is
ARTG 467571
Class Is
Gown, operating room, single use
ARTG ID: 467571
Good Name: Wiselink Group Pty Ltd - Gown, operating room, single use
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The surgical gowns are specially designed for the medical staff entering the operating room for operation. During surgery, the surgical gowns are worn on the medical staff to prevent the transmission of infectious agents between patients and medical staff during the operation and other invasive examinations. Type A: for medical staff, interns or visitors, it is a rear lace up structure. Type B: it can be worn by medical staff, scrub (instrument) nurses, surgical assistants and operators, and also by medical staff when special protection is required for special operations. It is full enclosing structure. Type C: reinforced surgical gowns are worn by the operator or medical staff when special protection is required for special operations. There are fabric stiffeners in specific areas in front of the chest and sleeves, which are full enclosing structure. It is applicable to the operation of patients with known infectious virus in their blood or unknown infectious virus in their blood during emergency rescue. Type D: it is packaged by multiple surgical gowns, which can provide surgical gowns for multiple medical staff at the same time.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
467571
Start Date
November 07, 2024
Effective Date
November 07, 2024
Manufacturer
Country
China
Address
No 39 Liaoyuan Road Xincheng Development Zone, Hefei, Anhui