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:
  • 218637
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218637

A R Medicom Australia Pty Ltd - Vinyl examination/treatment glove, non-powdered

ARTG entry for

Medical Device Included Class 1

Sponsor

A R Medicom Australia Pty Ltd

Postal Address

PO Box 226,THORNLEIGH, NSW, 2120

Australia

ARTG Start Date

18/12/2013

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

A R Medicom Inc Asia Ltd

21/F Federal Centre

77 Sheung On Street

, Chai Wan,

Hong Kong - SAR of China

Products

1. Vinyl examination/treatment glove, non-powdered

Product Type

Single Device Product

Effective date

18/12/2013

GMDN

47176 Vinyl examination/treatment glove, non-powdered

Intended purpose

A non-sterile single-use device that provide a protective barrier to reduce cross contanimation when worn

on the hands of a medical professional.

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 01.12.2017 at 07:15:07 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

19-11-2018

Dollarama recalls MONTOY Doll and Toy Furniture Set

Dollarama recalls MONTOY Doll and Toy Furniture Set

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.

Health Canada

26-9-2018

Boy Story LLC recalls Action Dolls

Boy Story LLC recalls Action Dolls

The joints on the vinyl dolls can break, creating broken pieces that pose a choking hazard to young children.

Health Canada

7-8-2018

Dollarama recalls the Skip Ball toy

Dollarama recalls the Skip Ball toy

The Skip Ball toy may contain levels of phthalates that exceed the allowable limit. 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.

Health Canada

There are no news related to this product.