Glove,

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Adam Dental Supplies
Class:
Class 1
Authorization status:
Included
Authorization number:
324184

Public Summary

Summary for ARTG Entry:

324184

Adam Dental Supplies - Glove, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Adam Dental Supplies

Postal Address

80/66 Kingsway Parade,GLEN WAVERLEY, VIC, 3150

Australia

ARTG Start Date

27/09/2019

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

CB Healthcare Consulting GmbH

Am Neumarkt 34

, Hamburg, 22041

Germany

Products

1. Glove, <specify>

Product Type

Single Device Product

Effective date

27/09/2019

GMDN

11879 Glove, <specify>

Intended purpose

This range of gloves helps act as a protective barrier between the user's hand or hands and the external

environment, typically be, e.g. an infection barrier between patient and healthcare provider or as an overall

protection of the skin of the hand and fingers. The range of gloves can be made of different materials and

can be of differing types.

Specific Conditions

© 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 02.11.2019 at 03:33:25 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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