Polychloroprene

Main information

  • Trade name:
  • Polychloroprene surgical glove, non-powdered
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Polychloroprene surgical glove, non-powdered
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217396
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217396

Ansell Ltd T/A Ansell Healthcare - Polychloroprene surgical glove, non-powdered

ARTG entry for

Medical Device Included Class IIa

Sponsor

Ansell Ltd T/A Ansell Healthcare

Postal Address

GPO Box 772 H,MELBOURNE, VIC, 3001

Australia

ARTG Start Date

16/11/2013

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Ansell Lanka (Pvt) Ltd

Biyagama Export Processing Zone

, Biyagama,

Sri Lanka

Products

1. Polychloroprene surgical glove, non-powdered

Product Type

Single Device Product

Effective date

16/11/2013

GMDN

57970 Polychloroprene surgical glove, non-powdered

Intended purpose

A sterile surgical glove made of polychloroprene (neoprene) intended as a protective barrier when worn on

the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder.

It is used mainly as a two-way barrier to protect patient and staff from microorganisms 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 http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.12.2017 at 04:57:14 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