Pure Global

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 Numedical Pty Ltd, manufactured by PT Haloni Jane TBK in Indonesia. The device registration started on May 24, 2024.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
Class I
Hevea-latex examination/treatment glove, non-powdered
Australia TGA ARTG Registered Device
Good Name: Numedical Pty Ltd - Hevea-latex examination/treatment glove, non-powdered
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Hevea-latex examination/treatment glove, non-powdered, non-sterile; A non-sterile device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 24, 2024
Effective Date
May 24, 2024
Manufacturer
Country
Indonesia
Address
JL Raya Serang KM 138, Kawasan Industri Tristate RT02RW01, Tangerang, Cikupa, 15710