Vinyl

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220206
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220206

Lorchant Enterprises - Vinyl examination/treatment glove, non-powdered

ARTG entry for

Medical Device Included Class 1

Sponsor

Lorchant Enterprises

Postal Address

PO Box 2261,GLADSTONE PARK, VIC, 3043

Australia

ARTG Start Date

17/02/2014

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

Medenstar Industries

133 Linping Road

Shanghai, ,

China

Products

1. Vinyl examination/treatment glove, non-powdered

Product Type

Single Device Product

Effective date

17/02/2014

GMDN

47176 Vinyl examination/treatment glove, non-powdered

Intended purpose

Vinyl powderfree gloves for handling of items

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 04:55:01 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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The plastic doll and furniture toy set contains levels of phthalates that exceed the allowable limit and may pose a chemical hazard. Studies suggest that certain phthalates, including DEHP, may cause reproductive and developmental abnormalities in young children when soft vinyl products containing phthalates are sucked or chewed for extended periods.

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