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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 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
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
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: 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: 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
ARTG number: 332848
Sponsor-initiated cancellation
Sponsor: Precision Surgical Pty Ltd
Manufacturer: Hubei HongKang Protective Products Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332852
Sponsor-initiated cancellation
Sponsor: MD Solutions Australasia Pty Ltd
Manufacturer: Henan Huibo Medical Co Ltd
Device/Product name: Airway protection face mask
ARTG number: 332929
Sponsor-initiated cancellation
Sponsor: Helay Import and Trading Pty Ltd
Manufacturer: Shandong Rientech Medical Tech Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332935
Sponsor-initiated cancellation
Sponsor: ADSone Group Pty Ltd
Manufacturer: Wenzhou Zhongjie Plastic Products Co Ltd
Device/Product name: Public respirator, single-use