Australia TGA ARTG record

Nitrile examination/treatment glove, non-powdered

Australia TGA ARTG Registered Device · Numedical Pty Ltd · Supermax Glove Manufacturing Sdn Bhd · Class I · Started January 11, 2022

Good Name: Numedical Pty Ltd - Nitrile examination/treatment glove, non-powdered

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: January 11, 2022
Effective Date: January 11, 2022

Sponsor

Name: Numedical Pty Ltd

Manufacturer

Name: Supermax Glove Manufacturing Sdn Bhd
Country: Malaysia
Address: Lot 38 Putra Industrial Park Bukit Rahman Putra 47000 Sungai Buloh, Selangor, Darul Ensan

Intended purpose

Nitrile examination/treatment glove, non-powdered, non-sterile; A non-sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

About this record

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 Numedical Pty Ltd, manufactured by Supermax Glove Manufacturing Sdn Bhd in Malaysia. The device registration started on January 11, 2022.

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.