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Post-market review of face masks: Cancelled ARTG entries
The Therapeutic Goods Administration (TGA) is undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). This page lists all face masks cancelled from the ARTG during the review. For general information about the review, including guidance for suppliers and users of face masks, see Post-market review of face masks: Overview.
Cancelled face mask ARTG entries
The ARTG entry for a face mask may be cancelled in two ways: (1) The sponsor (the supplier within Australia) may voluntarily cancel the entry or (2) the TGA may cancel the entry. With respect to the ARTG entries voluntarily cancelled by the sponsor, it is important to note that some of these devices may not be subject to a recall action. This is because the TGA may not have received any evidence for those entries about their compliance to any manufacturing standards. The TGA holds no evidence these devices meet appropriate manufacturing standards or failed to perform as intended. The decision to cancel the ARTG entry was made solely by the sponsor.
Upon applying for an ARTG inclusion, the sponsor certifies that they have evidence to support the devices safety and performance and that the device meets the Essential Principles or that the information can be obtained from the manufacturer within a specified timeframe. Therefore, it is expected that the manufacturer holds certain kinds of evidence (such as test reports to a nominated standard) to support the devices performance.
Where a face mask does not meet all the necessary regulatory requirements (e.g. non-conformance with the Essential Principles, failed laboratory testing, etc.) and/or is not performing as intended, consideration of where these masks are being used and if they pose an unacceptable risk to health and safety, including in healthcare settings is occurring. If the TGA determines that the risk is unacceptable and that manufacturer is unable to provide sufficient evidence to support the face masks performance, the TGA may decide to cancel the entry from the ARTG.
The TGA may decide not to cancel an ARTG entry due to administrative matters that can be addressed, where these masks meet all specifications and standards, and there are no deficiencies in safety, quality, performance or presentation.
For more information about face masks visit Face masks and COVID-19.
The following entries have been cancelled from the ARTG.
Displaying 1 - 25 of 1481
ARTG number: 110168
Sponsor-initiated cancellation
Sponsor: Henry Schein Halas
Manufacturer: Sultan Chemists Inc
Device/Product name: Mask, surgical, single use
ARTG number: 111500
Sponsor-initiated cancellation
Sponsor: Henry Schein Halas
Manufacturer: Alpha Pro Tech Inc
Device/Product name: Mask, surgical, single use
ARTG number: 113375
Sponsor-initiated cancellation
Sponsor: Henry Schein Halas
Manufacturer: Henry Schein Inc
Device/Product name: Mask
ARTG number: 114415
Sponsor-initiated cancellation
Sponsor: Paradise PVC Welding Pty Ltd
Manufacturer: Paradise PVC Pty Ltd
Device/Product name: Mask, <specify>
ARTG number: 117108
Sponsor-initiated cancellation
Sponsor: Tollot Pty Ltd T/a Aaxis Pacific
Manufacturer: Shanghai Dasheng Health Products Manufacturer Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 118587
Sponsor-initiated cancellation
Sponsor: Lorchant Enterprises
Manufacturer: Med-Con (Thailand) Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 120505
Sponsor-initiated cancellation
Sponsor: W9 Pty Ltd
Manufacturer: Crosstex International
Device/Product name: Mask, surgical, single use
ARTG number: 131312
Sponsor-initiated cancellation
Sponsor: Critical Dental Pty Ltd
Manufacturer: QuanZhou Eversafe Non-Woven Products Co Limited
Device/Product name: Mask, surgical, single use
ARTG number: 154722
Sponsor-initiated cancellation
Sponsor: Horseley Dental Supplies Pty Ltd
Manufacturer: Crosstex International
Device/Product name: Mask, surgical, single use
ARTG number: 155560
Sponsor-initiated cancellation
Sponsor: Orien Dental Supplies
Manufacturer: Mydent International
Device/Product name: Mask, surgical, single use
ARTG number: 164483
Sponsor-initiated cancellation
Sponsor: Henry Schein Halas
Manufacturer: Sultan Chemists Inc
Device/Product name: Mask
ARTG number: 167060
Sponsor-initiated cancellation
Sponsor: GlaxoSmithKline Australia Pty Ltd
Manufacturer: Sperian Protection Armor SAS
Device/Product name: Mask, <specify>
ARTG number: 171752
Sponsor-initiated cancellation
Sponsor: Livingstone International Pty Ltd
Manufacturer: Livingstone International Pty Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 179560
Sponsor-initiated cancellation
Sponsor: Xcellent Dental World
Manufacturer: Sunsmed Protective Products Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 180981
Sponsor-initiated cancellation
Sponsor: Medline International Two Australia Pty Ltd
Manufacturer: Medline International France SAS
Device/Product name: Mask, surgical, single use
ARTG number: 181189
Sponsor-initiated cancellation
Sponsor: Clean Room Garments Pty Ltd
Manufacturer: Rizao Sanqi Medical & Health Articles Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 184335
Sponsor-initiated cancellation
Sponsor: Sincere Medical Australia Pty Ltd
Manufacturer: Sincere Medical Australia Pty Ltd
Device/Product name: Mask, <specify>
ARTG number: 186039
Sponsor-initiated cancellation
Sponsor: 3M Australia Pty Ltd
Manufacturer: 3M United Kingdom Plc
Device/Product name: Mask, surgical, single use
ARTG number: 195434
Sponsor-initiated cancellation
Sponsor: Disposable Medical Supplies Pty Ltd
Manufacturer: Mydent International
Device/Product name: Mask, <specify>
ARTG number: 196062
Sponsor-initiated cancellation
Sponsor: Supergloves Australia Pty Ltd
Manufacturer: Wuhan Carestar Protective Products CoLtd
Device/Product name: Mask, surgical, single use
ARTG number: 205488
Sponsor-initiated cancellation
Sponsor: W9 Pty Ltd
Manufacturer: Mydent International
Device/Product name: Mask, surgical, single use
ARTG number: 206223
Sponsor-initiated cancellation
Sponsor: Tollot Pty Ltd T/a Aaxis Pacific
Manufacturer: Tianchang Dongan Protective Equipment Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 210481
Sponsor-initiated cancellation
Sponsor: Clifford Hallam Healthcare Pty Ltd
Manufacturer: priMED Medical Products Inc
Device/Product name: Mask, surgical, single use
ARTG number: 212766
Sponsor-initiated cancellation
Sponsor: Evershine Dental Pty Ltd
Manufacturer: Shanghai Zogear Industries Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 213176
Sponsor-initiated cancellation
Sponsor: One Dental Pty Ltd
Manufacturer: Changzhou Primed Medical Products Co Ltd
Device/Product name: Mask, surgical, single use