Main information

  • Trade name:
  • Hevea-latex examination/treatment glove, non-powdered
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Hevea-latex examination/treatment glove, non-powdered
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218661
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


A R Medicom Australia Pty Ltd - Hevea-latex examination/treatment glove, non-powdered

ARTG entry for

Medical Device Included Class 1


A R Medicom Australia Pty Ltd

Postal Address

PO Box 226,THORNLEIGH, NSW, 2120


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.




A R Medicom Inc Asia Ltd

21/F Federal Centre

77 Sheung On Street

, Chai Wan,

Hong Kong - SAR of China


1. Hevea-latex examination/treatment glove, non-powdered

Product Type

Single Device Product

Effective date



47172 Hevea-latex examination/treatment glove, non-powdered

Intended purpose

A non-sterile single-use device that provide a protective barrier to reduce cross contamination when worn

on the hands of a medical professional.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 01.12.2017 at 07:14:32 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information


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