Australia flagARTG 380851

Nitrile examination/treatment glove, non-powdered

ARTG ID: 380851 · Numedical Pty Ltd · Zhonghong Pulin Medical Products Co Ltd · Class I · Started December 15, 2021

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
ARTG ID
380851
Start Date
December 15, 2021
Effective Date
December 15, 2021
Sponsor
Manufacturer
Country
China
Address
West Industrial Park Luannan County, Tangshan, Hebei, 063500
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 registered under ARTG number 380851 and sponsored by Numedical Pty Ltd, manufactured by Zhonghong Pulin Medical Products Co Ltd in China. The device registration started on December 15, 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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