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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 176 - 200 of 1849

Enter an ARTG number, sponsor, manufacturer or product name

ARTG number: 332811

Sponsor-initiated cancellation

Sponsor: Simba Textile Mills Pty Ltd

Manufacturer: Anhui Chenrui Pharmaceutical Packaging Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332812

Sponsor-initiated cancellation

Sponsor: Equinox Orthopaedics Pty Ltd

Manufacturer: Safe Secure Packing Shenzhen Co Ltd

Device/Product name: Surgical/medical respirator, single-use

ARTG number: 332813

Sponsor-initiated cancellation

Sponsor: ADSone Group Pty Ltd

Manufacturer: Zhengzhou Ruipu Medical Technology Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 332814

Sponsor-initiated cancellation

Sponsor: ANSIC Pty Ltd

Manufacturer: Shenzhen Tonghua Weiye Technology Co Ltd

Device/Product name: Surgical/medical respirator, single-use

ARTG number: 332815

Sponsor-initiated cancellation

Sponsor: ANSIC Pty Ltd

Manufacturer: Yangzhou Zhongxin Medical Science And Technology Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332816

Sponsor-initiated cancellation

Sponsor: Simba Textile Mills Pty Ltd

Manufacturer: Anhui Chenrui Pharmaceutical Packaging Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332817

Sponsor-initiated cancellation

Sponsor: Perios Pty Ltd

Manufacturer: Jiangsu Nanfang Medical Co Ltd

Device/Product name: Mask, <specify>

ARTG number: 332818

Sponsor-initiated cancellation

Sponsor: Purist Australian

Manufacturer: Nantong Gather Excellence-Cleaning Medical Materials Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332819

TGA cancellation

Sponsor: DTC Project Imports

Manufacturer: Guangzhou aiyinmei Co Ltd

Device/Product name: Airway protection face mask

Additional information:

  • Reason for cancellation: 41GM(1) - Non response to a s41JA

ARTG number: 332820

Sponsor-initiated cancellation

Sponsor: Tinawells Pty Ltd

Manufacturer: Dongguan HuaGang Communication Technology Co Ltd

Device/Product name: Mask, surgical, reusable

ARTG number: 332822

Sponsor-initiated cancellation

Sponsor: RNA Pharmaceuticals Pty Ltd

Manufacturer: Yiwu Floating God Clothing Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332823

Sponsor-initiated cancellation

Sponsor: RNA Pharmaceuticals Pty Ltd

Manufacturer: Shenzhen Zhishan Medical Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332824

Sponsor-initiated cancellation

Sponsor: RNA Pharmaceuticals Pty Ltd

Manufacturer: Jiangxi Zhongchen Keji Co Ltd

Device/Product name: Mask, surgical, reusable

ARTG number: 332827

Sponsor-initiated cancellation

Sponsor: IMMERSIFAI PTY LTD

Manufacturer: Lakshan Global Solutions

Device/Product name: Mask, surgical, single use

ARTG number: 332828

Sponsor-initiated cancellation

Sponsor: IMMERSIFAI PTY LTD

Manufacturer: Lakshan Global Solutions

Device/Product name: Mask, <specify>

ARTG number: 332829

Sponsor-initiated cancellation

Sponsor: LYL Investment Pty Ltd

Manufacturer: Guangzhou Huize Pharmaceutical Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332829

Sponsor-initiated cancellation

Sponsor: LYL Investment Pty Ltd

Manufacturer: Guangzhou Huize Pharmaceutical Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332832

Sponsor-initiated cancellation

Sponsor: Legend Corporation Limited

Manufacturer: Legend Corporation Limited

Device/Product name: Public respirator, single-use

ARTG number: 332833

Sponsor-initiated cancellation

Sponsor: Jointown Healthcare Pty Ltd

Manufacturer: Xiantao Zhibo Non-woven Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332835

TGA cancellation

Sponsor: Histar Tradings Pty Ltd

Manufacturer: Henan Yizhong Medical Instrument Co Ltd

Device/Product name: Mask, surgical, single use

Additional information:

  • Reason for cancellation: 41GM(1) - Non response to a s41JA

ARTG number: 332836

Sponsor-initiated cancellation

Sponsor: Biovent Consulting Pty Ltd

Manufacturer: Zhuhai Qingchunyu Biotechnology Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332837

Sponsor-initiated cancellation

Sponsor: Vicki Partridge Pty Ltd

Manufacturer: Dandong Devote Garment Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332842

Sponsor-initiated cancellation

Sponsor: Ozmed Supplies Pty Ltd

Manufacturer: Yibin Grace New Materials Limited Corporation

Device/Product name: Mask, surgical, single use

ARTG number: 332843

Sponsor-initiated cancellation

Sponsor: CFPC SINGAPORE PTE LTD

Manufacturer: Shanghai Dasheng Health Products Manufacturer Co Ltd

Device/Product name: Surgical/medical respirator, single-use

ARTG number: 332844

TGA cancellation

Sponsor: AC Medical Supplies Pty Ltd

Manufacturer: Henan Yizhong Medical Instrument Co Ltd

Device/Product name: Mask, surgical, single use

Additional information:

  • Reason for cancellation: 41GL(e) - incorrect classification

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