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Nitrile examination/treatment glove, non-powdered

Access comprehensive regulatory information for Nitrile examination/treatment glove, non-powdered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Apollo Safety Health Consumables Pty Ltd, manufactured by Blue Sail Medical Co Ltd in China. The device registration started on September 01, 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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TGA ARTG Official Data
Class I
Class I
Nitrile examination/treatment glove, non-powdered
Australia TGA ARTG Registered Device
Good Name: Apollo Safety Health Consumables Pty Ltd - Nitrile examination/treatment glove, non-powdered
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Intended Purpose

Manufacturer - Blue Sail Medical Co., Ltd. - Nitrile Blue 4.0g Powder Free Non-Sterile Medical Grade Examination Gloves. "Bluesteel" product name by Apollo Safety Health Consumables Pty Ltd. The intended purpose of the gloves are to protect healthcare professionals such as Doctors, Nurses, Dentists, Aged Care workers to use when conducting personal examinations / care for patients, as they may come into contact with blood, urine, feces and other bodily fluids. The gloves are for single use only.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 01, 2021
Effective Date
September 01, 2021
Manufacturer
Country
China
Address
No 21 Qingtian Road Qilu Chemical Industrial Park, Zibo, Shandong, 255414