Gown

Main information

  • Trade name:
  • Gown, isolation, single use
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Gown, isolation, single use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220394
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220394

Multigate Medical Products Pty Ltd - Gown, isolation, single use

ARTG entry for

Medical Device Included Class Is

Sponsor

Multigate Medical Products Pty Ltd

Postal Address

27 Llewellyn Avenue,VILLAWOOD, NSW, 2163

Australia

ARTG Start Date

22/02/2014

Product category

Medical Device Class Is

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

Multigate Co Ltd

No 7 Lanjiang Road

Shaoxing, , 312000

China

Products

1. Gown, isolation, single use

Product Type

Single Device Product

Effective date

22/02/2014

GMDN

35492 Gown, isolation, single use

Intended purpose

A multipurpose garment, made of natural, synthetic or a combination of materials, worn by healthcare

providers or visitors to isolate them from the patient. Intended to be used as protection against infectious

or contagious agents.

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 04:14:12 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