Australia TGA ARTG recordGown, operating room, single use
Australia TGA ARTG Registered Device · QLife Group Pty Ltd · Henan Robestain Medical Products Co Ltd · Class Is · Started January 25, 2021
Good Name: QLife Group Pty Ltd - Gown, operating room, single use
- Risk Class
- Class Is
- Product Type
- Procedure Pack
- ARTG Category
- General
- Start Date
- January 25, 2021
- Effective Date
- January 25, 2021
- Country
- China
- Address
- No 590 Zhangnan Industry Zone Zhangsanzhai Town, Changyuan County, Henan Province
A procedure pack containing, apart from a towel, a sterile multipurpose garment, made of natural, synthetic or a combination of these materials, worn over scrub suits during surgical procedures. Depending on its 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.
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 sponsored by QLife Group Pty Ltd, manufactured by Henan Robestain Medical Products Co Ltd in China. The device registration started on January 25, 2021.
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.