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Gown, isolation, single use

Access comprehensive regulatory information for Gown, isolation, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Palladium International Pty Ltd, manufactured by Sino Protection (Hefei) Medical Products Co Ltd in China. The device registration started on February 03, 2023.

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, isolation, single use
Australia TGA ARTG Registered Device
Good Name: Palladium International Pty Ltd - Gown, isolation, single use
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Intended Purpose

Isolation gown, single-use; A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 03, 2023
Effective Date
February 03, 2023
Manufacturer
Country
China
Address
Area B Xinzhan Industrial Park XingHuo road, Hefei, 230011