Australia TGA ARTG recordGown, operating room, single use
Australia TGA ARTG Registered Device · QLife Group Pty Ltd · Exact Medical Manufacturing Inc · Class I · Started April 25, 2020
Good Name: QLife Group Pty Ltd - Gown, operating room, single use
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- April 25, 2020
- Effective Date
- April 25, 2020
- Country
- United States of America
- Address
- 4917 William Street, Lancaster, NY, 14086
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.
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.