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Hevea-latex examination/treatment glove, non-powdered

Access comprehensive regulatory information for Hevea-latex 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 CGA Medical Supplies Pty Ltd, manufactured by Maxter Glove Manufacturing Sdn Bhd in Malaysia. The device registration started on November 21, 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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TGA ARTG Official Data
Class I
Class I
Hevea-latex examination/treatment glove, non-powdered
Australia TGA ARTG Registered Device
Good Name: CGA Medical Supplies Pty Ltd - Hevea-latex examination/treatment glove, non-powdered
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Intended Purpose

Hevea-latex examination/treatment gloves, non-powdered [47172] The manufacturing standards for the examination gloves are established by ISO13485:2016, ISO900:2015, ASTM D3578. The gloves provide an excellent barrier protection, allow excellent tactile sensitivity, remain non-reactivity when contacting patient or operator tissue, provide comfort over an extended period of time.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 21, 2023
Effective Date
November 21, 2023
Manufacturer
Country
Malaysia
Address
Lot 6070 Jalan Haji Abdul Manan, 6th Miles off Jalan Meru / 41050 Klang, Selangor Darul Ehsan