Gown

Main information

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

Documents

Localization

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

Other information

Status

  • 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:

219044

Bosco Medical Australia - Gown, operating room, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Bosco Medical Australia

Postal Address

2/49 Borthwick Avenue,MURARRIE, QLD, 4172

Australia

ARTG Start Date

9/01/2014

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

Guardian

Grangestone Girvan

, Ayrshire, KA269PF

Products

1. Gown, operating room, single use

Product Type

Single Device Product

Effective date

9/01/2014

GMDN

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