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Gown, operating room, single use - ARTG 466667

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 466667 and sponsored by ALMITAS GROUP INTERNATIONAL PTY LTD, manufactured by Xiantao Zhongtai Protective Products Co Ltd in China. The device registration started on October 31, 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.

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TGA ARTG Official Data
Class Is
ARTG 466667
Class Is
Gown, operating room, single use
ARTG ID: 466667
Good Name: ALMITAS GROUP INTERNATIONAL PTY LTD - Gown, operating room, single use
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Intended Purpose

A 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.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
466667
Start Date
October 31, 2024
Effective Date
October 31, 2024
Manufacturer
Country
China
Address
3# Taizi Lake Industry Park Pengchang Town, Xiantao Hubei, 433018