Hevea-latex

Main information

  • Trade name:
  • Hevea-latex examination/treatment glove, non-powdered
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Hevea-latex examination/treatment glove, non-powdered
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219818
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219818

Betel Disposable Pty Ltd - Hevea-latex examination/treatment glove, non-powdered

ARTG entry for

Medical Device Included Class 1

Sponsor

Betel Disposable Pty Ltd

Postal Address

PO Box 562,FORESTVILLE, NSW, 2087

Australia

ARTG Start Date

3/02/2014

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

Betelcare Sdn Bhd

Lot 3342 Jalan Keretapi Lama

7 1/2 Mile off Jalan Kapar

Selangor Darul, Ehsan, 0

Malaysia

Products

1. Hevea-latex examination/treatment glove, non-powdered

Product Type

Single Device Product

Effective date

3/02/2014

GMDN

47172 Hevea-latex examination/treatment glove, non-powdered

Intended purpose

Disposable Latex Glove, Patient Examination

A non-sterile device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn

on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes;

its inner surface is not covered with talcum powder. The device is used mainly as a two-way barrier to

protect both the patient and the staff against various contamination. It will have appropriate characteristics

regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile

strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a

single-use device.

This glove contains Shea Butter & Aloe extract to hydrate & moisturise the hands of wearers.

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 06:29:46 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

19-4-2018

Fluad trivalent influenza vaccine

Fluad trivalent influenza vaccine

Safety advisory - risk to patients with latex allergy

Therapeutic Goods Administration - Australia

15-5-2018

Medicine labels: Guidance on TGO 91 and TGO 92

Medicine labels: Guidance on TGO 91 and TGO 92

The guidance for medicine labels has been updated to improve clarity for sponsors. It also includes new best practice on latex labelling.

Therapeutic Goods Administration - Australia