Visitor

Main information

  • Trade name:
  • Visitor hygiene coverall
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Visitor hygiene coverall
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220127
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220127

Plus Medical Pty Ltd - Visitor hygiene coverall

ARTG entry for

Medical Device Included Class 1

Sponsor

Plus Medical Pty Ltd

Postal Address

Suite 301 / Level 3 / 815 Pacific Highway,CHATSWOOD, NSW, 2067

Australia

ARTG Start Date

13/02/2014

Product category

Medical Device Class 1

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

Foshan Nanhai Plus Medical Co Ltd

Shatou Jiujiang Town Nanhai District Foshan

City

Guangdong Province, ,

China

Products

1. Visitor hygiene coverall

Product Type

Single Device Product

Effective date

13/02/2014

GMDN

58390 Visitor hygiene coverall

Intended purpose

A non-sterile coverall to be worn to help prevent cross contamination of infectious agents which is intended

to be singe-use only.

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 10.11.2017 at 05:12:05 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