Pure Global

Gown, operating room, single use

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 I is sponsored by QLife Group Pty Ltd, manufactured by Exact Medical Manufacturing Inc in United States of America. The device registration started on April 25, 2020.

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, operating room, single use
Australia TGA ARTG Registered Device
Good Name: QLife 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

A multipurpose garment, made of natural, synthetic or a combination of these materials, worn over scrub suits during surgical procedures. Depending on it's intended use, it may be fluid resistant or impervious to fluid. An operating room gown is used during surgical procedures to protect both the patient and operating room personnel from the transfer of micro-organisms, body fluids and particulate material. This is a disposable garment.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 25, 2020
Effective Date
April 25, 2020
Manufacturer
Country
United States of America
Address
4917 William Street, Lancaster, NY, 14086