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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 Sleepcraft Distributors Pty Ltd, manufactured by Wuxi JHT Group Co Ltd in China. The device registration started on April 23, 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.

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Class I
Class I
Gown, isolation, single use
Australia TGA ARTG Registered Device
Good Name: Sleepcraft Distributors Pty Ltd - Gown, isolation, single use
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Intended Purpose

A garment intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient 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
April 23, 2020
Effective Date
April 23, 2020
Manufacturer
Country
China
Address
66 Huichang Road Huishan Industrial Park, Wuxi, Jiangsu