Professional examination gown, reusable

Public Summary

Summary for ARTG Entry:

339723

Sacha Drake Pty Ltd - Professional examination gown, reusable

ARTG entry for

Medical Device Included Class 1

Sponsor

Sacha Drake Pty Ltd

Postal Address

Unit 1 12 Walker Street, Woolloongabba, QLD, 4102

Australia

ARTG Start Date

17/07/2020

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

Sacha Drake Pty Ltd

Unit 1 12 Walker Street

Woolloongabba, QLD, 4102

Australia

Products

1 . Professional examination gown, reusable

Product Type

Single Device Product

Effective Date

17/07/2020

GMDN

42305 Professional examination gown, reusable

Intended Purpose

A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits,

while examining patients. Depending upon its intended use, it may be fluid resistant or impervious to fluid. An examination gown is

used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as

microorganisms or body fluids. This is a reusable garment which can be cleaned for reuse.

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 22.07.2020 at 08:35:27 AEST

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