Main information

  • Trade name:
  • Nitrile examination/treatment glove, non-powdered, sterile
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Nitrile examination/treatment glove, non-powdered, sterile
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219755
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Ansell Ltd T/A Ansell Healthcare - Nitrile examination/treatment glove, non-powdered, sterile

ARTG entry for

Medical Device Included Class Is


Ansell Ltd T/A Ansell Healthcare

Postal Address

GPO Box 772 H,MELBOURNE, VIC, 3001


ARTG Start Date


Product category

Medical Device Class Is



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.




Ansell Healthcare Europe NV

Boulevard International 55

, Brussels, B-1070



1. Nitrile examination/treatment glove, non-powdered, sterile

Product Type

Single Device Product

Effective date



61631 Nitrile examination/treatment glove, non-powdered, sterile

Intended purpose

A sterile glove 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 talcum powder. The device is used mainly as a two-way barrier to protect patient/staff against

contaminants and risk of allergy to latex.

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

Public Summary

Page 1 of

Produced at 02.12.2017 at 04:34:16 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.

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There are no safety alerts related to this product.


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