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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 151 - 175 of 1849
ARTG number: 332685
Sponsor-initiated cancellation
Sponsor: C R Kennedy & Co Pty Ltd
Manufacturer: Nantong Boke Endo Medical Device Technology Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332686
Sponsor-initiated cancellation
Sponsor: M&S Health Solutions Pty Ltd
Manufacturer: Nantong Jianan Medical Products Co Ltd
Device/Product name: Surgical/medical respirator, single-use
ARTG number: 332687
Sponsor-initiated cancellation
Sponsor: Australis Agencies Pty Ltd
Manufacturer: Sanofi (Beijing) Pharmaceuticals Co., Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332690
Sponsor-initiated cancellation
Sponsor: Premier Healthcare Solutions and Supplies Pty Ltd
Manufacturer: Dongguan Medical Valley Biomedical Technology Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332691
Sponsor-initiated cancellation
Sponsor: Maph Pty Ltd
Manufacturer: Qingzhou Yaowang Pharmaceutical Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332692
TGA cancellation
Sponsor: Mason Corporation Pty Ltd
Manufacturer: Shenzhen Qingrui Medical Technology Co Ltd
Device/Product name: Mask, surgical, single-use
Additional information:
- Reason for cancellation: 41GN(1) - Failure to comply with a condition of inclusion
ARTG number: 332693
Sponsor-initiated cancellation
Sponsor: FLL Import Export Pty Ltd
Manufacturer: Tianchang City Sanhe Finery Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332696
Sponsor-initiated cancellation
Sponsor: FLL Import Export Pty Ltd
Manufacturer: Suzhou Letian Protective Products Co Ltd
Device/Product name: Public respirator, single-use
ARTG number: 332700
Sponsor-initiated cancellation
Sponsor: Medi Dent Disposable International
Manufacturer: Nanjing Sealand Medical Co Ltd
Device/Product name: Mask, <specify>
ARTG number: 332701
Sponsor-initiated cancellation
Sponsor: GLORADE INDUSTRIES PTY LTD
Manufacturer: Shanghai Dasheng Health Products Manufacturer Co Ltd
Device/Product name: Public respirator, single-use
ARTG number: 332787
Sponsor-initiated cancellation
Sponsor: Kadac Pty Ltd
Manufacturer: Puning Jianshun Protective Products Co Ltd
Device/Product name: Airway protection face mask
ARTG number: 332789
Sponsor-initiated cancellation
Sponsor: Australis Agencies Pty Ltd
Manufacturer: Xiantiao Dingcheng Non-Woven Products Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332791
Sponsor-initiated cancellation
Sponsor: M&S Health Solutions Pty Ltd
Manufacturer: Nantong Jianan Medical Products Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332792
Sponsor-initiated cancellation
Sponsor: Juslink (Aust) Pty Ltd
Manufacturer: Xiantao Sanda Industrial Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332794
Sponsor-initiated cancellation
Sponsor: Digital Dental Connect
Manufacturer: Guangdong Chundga New Materials Tech Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332795
Sponsor-initiated cancellation
Sponsor: ANSIC Pty Ltd
Manufacturer: Suzhou Letian Protective Products Co Ltd
Device/Product name: Surgical/medical respirator, single-use
ARTG number: 332796
Sponsor-initiated cancellation
Sponsor: Macquarie Medical Systems Pty Ltd
Manufacturer: Suzhou Sunmed Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332798
Sponsor-initiated cancellation
Sponsor: Innovative Medcare Technology Pty Ltd
Manufacturer: Foshan Nanhai Plus Medical Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332801
Sponsor-initiated cancellation
Sponsor: Allen Mason International Pty Ltd
Manufacturer: Guangdong Owgels Science & Technology Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332802
Sponsor-initiated cancellation
Sponsor: Allen Mason International Pty Ltd
Manufacturer: Guangdong Owgels Science & Technology Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332804
TGA cancellation
Sponsor: Meifan Technology (Australia) Pty Ltd
Manufacturer: Jiang Xi 3L Medical Products Group Co Ltd
Device/Product name: Mask, surgical, single use
Additional information:
- Reason for cancellation: 41GN(1) - Failure to comply with a condition of inclusion
ARTG number: 332805
TGA cancellation
Sponsor: Meifan Technology (Australia) Pty Ltd
Manufacturer: Jiang Xi 3L Medical Products Group Co Ltd
Device/Product name: Public N95 respirator
Additional information:
- Reason for cancellation: 41GN(1) - Failure to comply with a condition of inclusion
ARTG number: 332806
Sponsor-initiated cancellation
Sponsor: Ultra Business Solutions
Manufacturer: Anhui Yaxin Rubber Plastic Technology Development Co Ltd
Device/Product name: Airway protection face mask
ARTG number: 332807
Sponsor-initiated cancellation
Sponsor: Ultra Business Solutions
Manufacturer: Anhui Mengyang Technology Co Ltd
Device/Product name: Airway protection face mask
ARTG number: 332809
Sponsor-initiated cancellation
Sponsor: Simba Textile Mills Pty Ltd
Manufacturer: Tongcheng Chengfeng Protective Equipment Co Ltd
Device/Product name: Mask, surgical, single use