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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 SWISS MADE BRANDS PTY LTD, manufactured by 3A Medical Products Co Ltd in China. The device registration started on October 22, 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.

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Class I
Class I
Gown, operating room, single use
Australia TGA ARTG Registered Device
Good Name: SWISS MADE BRANDS PTY LTD - Gown, operating room, single use
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Intended Purpose

AAMI level 4 Isolation Gown A multipurpose garment, made of natural, synthetic or a combination of these materials, worn over scrub suits during surgical procedures. This 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
October 22, 2021
Effective Date
October 22, 2021
Manufacturer
Country
China
Address
Yu An Industrial Park, Liu An, 230001