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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 126 - 150 of 1849

Enter an ARTG number, sponsor, manufacturer or product name

ARTG number: 332477

Sponsor-initiated cancellation

Sponsor: Health One Pty Ltd

Manufacturer: Shanghai Dasheng Health Products Manufacturer Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 332479

Sponsor-initiated cancellation

Sponsor: Healtree Australian Pty Ltd

Manufacturer: Foshan Nanhai Plus Medical Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332547

Sponsor-initiated cancellation

Sponsor: Greencare Australia Pty Ltd

Manufacturer: Sunsmed Protective Products Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332548

Sponsor-initiated cancellation

Sponsor: Healtree Australian Pty Ltd

Manufacturer: Foshan Nanhai Plus Medical Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 332550

Sponsor-initiated cancellation

Sponsor: ANSIC Pty Ltd

Manufacturer: Tiantai Zhenxing Wiremesh Factory

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

ARTG number: 332554

Sponsor-initiated cancellation

Sponsor: Zenpharm Pty Ltd

Manufacturer: FuJian YingDaWo Medical Technology Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332555

TGA cancellation

Sponsor: Lavinia Medical Pty Ltd

Manufacturer: Xiantao Zhibo Non-woven Products Co Ltd

Device/Product name: Mask, surgical, single use

Additional information:

  • Reason for cancellation: Non-payment of annual charges

ARTG number: 332555

Sponsor-initiated cancellation

Sponsor: Lavinia Medical Pty Ltd

Manufacturer: Xiantao Zhibo Non-woven Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332557

Sponsor-initiated cancellation

Sponsor: Innovative Medcare Technology Pty Ltd

Manufacturer: Raysen (Tianjin) Healthcare Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332559

Sponsor-initiated cancellation

Sponsor: The Trustee for Online Brands Group Unit Trust

Manufacturer: Fujian Hanhe Nursing Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332561

Sponsor-initiated cancellation

Sponsor: XZ PTY LTD

Manufacturer: Jiangyin Baokoni Sanitary Protective Equipment Co Ltd

Device/Product name: Mask, <specify>

ARTG number: 332562

Sponsor-initiated cancellation

Sponsor: My Queen Pty Ltd

Manufacturer: Hubei Raineen Protective Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332563

TGA cancellation

Sponsor: Tinawells Pty Ltd

Manufacturer: Shandong Zhushi Pharmaceutical Group Co Ltd

Device/Product name: Mask, surgical, single use

Additional information:

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

ARTG number: 332564

Sponsor-initiated cancellation

Sponsor: TH Health Pty Ltd

Manufacturer: Guangdong Haiou Medical Apparatus Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332566

Sponsor-initiated cancellation

Sponsor: Crea8 Management Pty Ltd

Manufacturer: Xiantao Yi-Ya Protective Products Co Ltd

Device/Product name: Mask, <specify>

ARTG number: 332569

Sponsor-initiated cancellation

Sponsor: Care Essentials Pty Ltd

Manufacturer: Safecare Medical Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332601

Sponsor-initiated cancellation

Sponsor: Jointown Healthcare Pty Ltd

Manufacturer: Henan Yadu Industrial Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332604

TGA cancellation

Sponsor: Aidacare Pty Ltd

Manufacturer: Aidacare Pty Ltd

Device/Product name: Mask, surgical, single use

Additional information:

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

ARTG number: 332669

Sponsor-initiated cancellation

Sponsor: Bosco Medical Australia

Manufacturer: APK Technology Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332671

Sponsor-initiated cancellation

Sponsor: Bertram Consolidated Pty Ltd

Manufacturer: Dongguan Hao Yang Carbon Fiber Heating Puoducts Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 332672

Sponsor-initiated cancellation

Sponsor: Global Gateways

Manufacturer: Henan Yadu Industrial Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332674

Sponsor-initiated cancellation

Sponsor: E-TRIPLE PTY LTD

Manufacturer: Shanghai Zogear Industries Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332676

Sponsor-initiated cancellation

Sponsor: Drewson International Pty Ltd T/A Briggate Medical Company

Manufacturer: Leboo Healthcare Products Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332682

TGA cancellation

Sponsor: Jac International Trading Pty Ltd

Manufacturer: Xiantao Zhibo Non-woven Products Co Ltd

Device/Product name: Mask, surgical, single use

Additional information:

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

ARTG number: 332684

Sponsor-initiated cancellation

Sponsor: Crea8 Management Pty Ltd

Manufacturer: Xiantao Yongli Medical Products Co Ltd

Device/Product name: Mask, <specify>

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