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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 126 - 150 of 712
ARTG number: 332939
Sponsor-initiated cancellation
Sponsor: ASTER HOME NURSING SERVICE PTY LTD
Manufacturer: Henan Gore Medical Instruments Co Ltd
Device/Product name: Mask
ARTG number: 332942
Sponsor-initiated cancellation
Sponsor: The Fine Fragrance Company Pty Ltd
Manufacturer: Hubei Kimsoul Industrial Co Ltd
Device/Product name: Airway protection face mask
ARTG number: 332943
Sponsor-initiated cancellation
Sponsor: Australis Agencies Pty Ltd
Manufacturer: JinJiang Jiaxing Group Co Ltd
Device/Product name: Public respirator, single-use
ARTG number: 332975
Sponsor-initiated cancellation
Sponsor: E & L May Pty Ltd
Manufacturer: Tongcheng Aimei labor protection products Co Ltd
Device/Product name: Mask
ARTG number: 332983
Sponsor-initiated cancellation
Sponsor: ANSIC Pty Ltd
Manufacturer: Foshan Nanhai Weijian Sanbang Protective Equipment Technology Co Ltd
Device/Product name: Surgical/medical respirator, single-use
ARTG number: 332984
Sponsor-initiated cancellation
Sponsor: ANSIC Pty Ltd
Manufacturer: Shenzhen CYX Technology Co Ltd
Device/Product name: Surgical/medical respirator, single-use
ARTG number: 332985
Sponsor-initiated cancellation
Sponsor: ANSIC Pty Ltd
Manufacturer: Shenzhen CYX Technology Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332986
Sponsor-initiated cancellation
Sponsor: ANSIC Pty Ltd
Manufacturer: Qingzhou Yaowang Pharmaceutical Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332987
Sponsor-initiated cancellation
Sponsor: Innovative Medcare Technology Pty Ltd
Manufacturer: Henan Huibo Medical Co Ltd
Device/Product name: Surgical/medical respirator, single-use
ARTG number: 332988
Sponsor-initiated cancellation
Sponsor: PERTH DENTAL SUPPLIES PTY LTD
Manufacturer: Xiantao Sanda Industrial Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 332991
Sponsor-initiated cancellation
Sponsor: Niagara Australia Pty Ltd
Manufacturer: Leephick Pharmaceutic Industry Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333061
Sponsor-initiated cancellation
Sponsor: Sutherland Medical Pty Limited
Manufacturer: Changsha Jneyl Medical Equipment Co Ltd
Device/Product name: Mask, <specify>
ARTG number: 333068
Sponsor-initiated cancellation
Sponsor: THE SYDNEY COSMETIC SPECIALIST CLINIC PTY LTD
Manufacturer: SHANGHAI EARNTZ NONWOVEN LTD
Device/Product name: Surgical/medical respirator, single-use
ARTG number: 333079
Sponsor-initiated cancellation
Sponsor: Sydicare Pty Ltd
Manufacturer: Dongguan Maisichuang Textile Technology Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333081
TGA cancellation
Sponsor: Biovent Consulting Pty Ltd
Manufacturer: Wuhan ZeruiHealth Gene Technology Co Ltd
Device/Product name: Mask, surgical, single use
Additional information:
- Reason for cancellation: 41GM(1) - Non response to a s41JA
ARTG number: 333082
Sponsor-initiated cancellation
Sponsor: Biovent Consulting Pty Ltd
Manufacturer: Jiande Chaomei Daily Chemicals Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333087
Sponsor-initiated cancellation
Sponsor: ANSIC Pty Ltd
Manufacturer: Tangshan Yuchuang Protective Equipment Co Ltd
Device/Product name: Surgical/medical respirator, single-use
ARTG number: 333097
Sponsor-initiated cancellation
Sponsor: Care Essentials Pty Ltd
Manufacturer: Wenzhou Ouwojie Commodity Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333126
Sponsor-initiated cancellation
Sponsor: Avacare Australia Pty Ltd
Manufacturer: Flexitex
Device/Product name: Mask, surgical, single use
ARTG number: 333128
Sponsor-initiated cancellation
Sponsor: Ultimatum Pty Ltd
Manufacturer: Ningbo Shisha Houseware Co Ltd
Device/Product name: Public respirator, single-use
ARTG number: 333130
Sponsor-initiated cancellation
Sponsor: Orthocare Pty Ltd
Manufacturer: AC Mould Simple Medical
Device/Product name: Mask, surgical, single use
ARTG number: 333134
Sponsor-initiated cancellation
Sponsor: De La Fontaine Australia Pty Ltd
Manufacturer: Dongguan HuaGang Communication Technology Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333135
Sponsor-initiated cancellation
Sponsor: Innovative Medcare Technology Pty Ltd
Manufacturer: Henan Huibo Medical Co Ltd
Device/Product name: Public respirator, single-use
ARTG number: 333164
Sponsor-initiated cancellation
Sponsor: AL Mind & Health Pty Ltd
Manufacturer: Zhuhai Qingchunyu Biotechnology Co Ltd
Device/Product name: Public respirator, single-use
ARTG number: 333166
Sponsor-initiated cancellation
Sponsor: AL Mind & Health Pty Ltd
Manufacturer: Hubei Mingerkang Health & Safety Applicances Co Ltd
Device/Product name: Mask, surgical, single use