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Post-market review of face masks: Cancelled ARTG entries

8 July 2022

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

Enter an ARTG number, sponsor, manufacturer or product name

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

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