Main information

  • Trade name:
  • Gown, operating room, single use
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Gown, operating room, single use
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219044
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Bosco Medical Australia - Gown, operating room, single use

ARTG entry for

Medical Device Included Class 1


Bosco Medical Australia

Postal Address

2/49 Borthwick Avenue,MURARRIE, QLD, 4172


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.





Grangestone Girvan

, Ayrshire, KA269PF

United Kingdom


1. Gown, operating room, single use

Product Type

Single Device Product

Effective date



35091 Gown, operating room, single use

Intended purpose

A multipurpose garment, made of natural, synthetic or a combination of these materials, worn over scrub

suits during surgical procedures. Depending on its intended use, it may be fluid resistant or impervious to

fluid. An operating room gown is used during surgical procedures to protect both the patient and operating

room personnel from the transfer of micro-organisms, body fluids and particulate material. This is a

disposable garment.

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 08:35:10 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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