Post-market review of face masks: Cancelled ARTG entries

14 January 2021

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 these devices are not subject to a recall action. This is because the TGA has not received any evidence for those entries about their compliance to any manufacturing standards. The TGA holds no evidence these devices failed to meet appropriate manufacturing standards or failed to perform as intended. The decision to cancel the ARTG entry was made solely by the sponsor.

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.

For example, 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.

The following entries have been cancelled from the ARTG.

Displaying 101 - 125 of 712

ARTG number: 332806

Sponsor-initiated cancellation

Manufacturer: Anhui Yaxin Rubber Plastic Technology Development Co Ltd

Device/Product name: Airway protection face mask

ARTG number: 332807

Sponsor-initiated cancellation

Manufacturer: Anhui Mengyang Technology Co Ltd

Device/Product name: Airway protection face mask

ARTG number: 332809

Sponsor-initiated cancellation

Manufacturer: Tongcheng Chengfeng Protective Equipment Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332811

Sponsor-initiated cancellation

Manufacturer: Anhui Chenrui Pharmaceutical Packaging Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332812

Sponsor-initiated cancellation

Manufacturer: Safe Secure Packing Shenzhen Co Ltd

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

ARTG number: 332813

Sponsor-initiated cancellation

Manufacturer: Zhengzhou Ruipu Medical Technology Co Ltd

Device/Product name: Public respirator, single-use

ARTG number: 332814

Sponsor-initiated cancellation

Manufacturer: Shenzhen Tonghua Weiye Technology Co Ltd

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

ARTG number: 332815

Sponsor-initiated cancellation

Manufacturer: Yangzhou Zhongxin Medical Science And Technology Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332816

Sponsor-initiated cancellation

Manufacturer: Anhui Chenrui Pharmaceutical Packaging Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332817

Sponsor-initiated cancellation

Manufacturer: Jiangsu Nanfang Medical Co Ltd

Device/Product name: Mask, <specify>

ARTG number: 332820

Sponsor-initiated cancellation

Manufacturer: Dongguan HuaGang Communication Technology Co Ltd

Device/Product name: Mask, surgical, reusable

ARTG number: 332822

Sponsor-initiated cancellation

Manufacturer: Yiwu Floating God Clothing Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332823

Sponsor-initiated cancellation

Manufacturer: Shenzhen Zhishan Medical Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332824

Sponsor-initiated cancellation

Manufacturer: Jiangxi Zhongchen Keji Co Ltd

Device/Product name: Mask, surgical, reusable

ARTG number: 332833

Sponsor-initiated cancellation

Manufacturer: Xiantao Zhibo Non-woven Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332835

TGA cancellation

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

Manufacturer: Zhuhai Qingchunyu Biotechnology Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332837

Sponsor-initiated cancellation

Manufacturer: Dandong Devote Garment Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332842

Sponsor-initiated cancellation

Manufacturer: Yibin Grace New Materials Limited Corporation

Device/Product name: Mask, surgical, single use

ARTG number: 332843

Sponsor-initiated cancellation

Manufacturer: Shanghai Dasheng Health Products Manufacturer Co Ltd

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

ARTG number: 332844

TGA cancellation

Manufacturer: Henan Yizhong Medical Instrument Co Ltd

Device/Product name: Mask, surgical, single use

Additional information:

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

ARTG number: 332848

Sponsor-initiated cancellation

Manufacturer: Hubei HongKang Protective Products Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332852

Sponsor-initiated cancellation

Manufacturer: Henan Huibo Medical Co Ltd

Device/Product name: Airway protection face mask

ARTG number: 332929

Sponsor-initiated cancellation

Manufacturer: Shandong Rientech Medical Tech Co Ltd

Device/Product name: Mask, surgical, single use

ARTG number: 332935

Sponsor-initiated cancellation

Manufacturer: Wenzhou Zhongjie Plastic Products Co Ltd

Device/Product name: Public respirator, single-use

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