Events

Recall of Supergloves Vinyl Examination Gloves, powdered & powder free

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Supergloves Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01481-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01481-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Testing by the tga has found that supergloves vinyl examination gloves are not suitable for medical/biological applications because they do not provide an effective barrier suitable for medical or biological protection.
  • Action
    Supergloves Australia Pty Ltd is advising all customers & distributors to quarantine all Supergloves Vinyl Examination Gloves with ARTG # 196064 printed on the box and to contact Supergloves who will arrange for the stocks to be recovered and a credit note issued. This action has been closed-out on 23/05/2017.

Device

Supergloves Vinyl Examination Gloves, powdered & powder free
  • Model / Serial
    Supergloves Vinyl Examination Gloves, powdered & powder freeAll batchesARTG Number: 196064
  • Manufacturer
    Supergloves Australia Pty Ltd

Manufacturer

Supergloves Australia Pty Ltd
  • Source
    DHTGA