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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 176 - 200 of 712
ARTG number: 333378
Sponsor-initiated cancellation
Sponsor: Xcellent Dental World
Manufacturer: Shanghai Zogear Industries Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333380
Sponsor-initiated cancellation
Sponsor: Nutagenix Health Labs Pty Ltd
Manufacturer: Shanghai Dasheng Health Products Manufacturer Co Ltd
Device/Product name: Public respirator, single-use
ARTG number: 333381
Sponsor-initiated cancellation
Sponsor: PERTH DENTAL SUPPLIES PTY LTD
Manufacturer: Biobase Scientific (Shandong) Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333387
Sponsor-initiated cancellation
Sponsor: Dateline Imports Pty Ltd
Manufacturer: Guangzhou Fourto Sanitary Products Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333388
Sponsor-initiated cancellation
Sponsor: Graysons Commercial
Manufacturer: Wuxi Yushou Medical Appliances Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333391
Sponsor-initiated cancellation
Sponsor: Bertram Consolidated Pty Ltd
Manufacturer: Guangzhou bofite safety protective equipment Co Ltd
Device/Product name: Public respirator, single-use
ARTG number: 333393
Sponsor-initiated cancellation
Sponsor: Medical Devices and Testing Pty Ltd
Manufacturer: Anhui Easyway Medical Supplies Co Ltd
Device/Product name: Public respirator, single-use
ARTG number: 333396
Sponsor-initiated cancellation
Sponsor: Enzo4D Pty Ltd
Manufacturer: ShenZhen Lijiang Health Technology Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333398
Sponsor-initiated cancellation
Sponsor: Medical Devices and Testing Pty Ltd
Manufacturer: Dongguan HuaGang Communication Technology Co Ltd
Device/Product name: Public respirator, single-use
ARTG number: 333403
Sponsor-initiated cancellation
Sponsor: MEDICAL CANNABIS AUSTRALIA PTY LTD
Manufacturer: Henan Huibo Medical Co Ltd
Device/Product name: Public respirator, single-use
ARTG number: 333405
Sponsor-initiated cancellation
Sponsor: Icon International Pty Ltd t/a Icon Medipharm
Manufacturer: Hubei Xianmeng Health Protection Commodity Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333406
Sponsor-initiated cancellation
Sponsor: MEDICAL CANNABIS AUSTRALIA PTY LTD
Manufacturer: Henan Huibo Medical Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333408
Sponsor-initiated cancellation
Sponsor: Wiselink Group Pty Ltd
Manufacturer: Safe Secure Packing Shenzhen Co Ltd
Device/Product name: Public respirator, single-use
ARTG number: 333410
Sponsor-initiated cancellation
Sponsor: THE SYDNEY COSMETIC SPECIALIST CLINIC PTY LTD
Manufacturer: SHANGHAI EARNTZ NONWOVEN LTD
Device/Product name: Public respirator, single-use
ARTG number: 333411
Sponsor-initiated cancellation
Sponsor: Graysons Commercial
Manufacturer: Henan Yu'an Medical Science and Technology Development Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333412
TGA cancellation
Sponsor: Life Biotech Pty Ltd
Manufacturer: HOMAR BIO TECHNOLOGY (GUANGZHOU) HOLDING CO LTD
Device/Product name: Public respirator, single-use
Additional information:
- Reason for cancellation: S41GM(1) - Non response to a s41JA
ARTG number: 333413
Sponsor-initiated cancellation
Sponsor: Vicki Partridge Pty Ltd
Manufacturer: Hebei Shengteng Medical Devices Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333415
Sponsor-initiated cancellation
Sponsor: 7TH BRAND PTY LTD
Manufacturer: Henan Yadu Industrial Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333416
Sponsor-initiated cancellation
Sponsor: Atris Pty Ltd
Manufacturer: Henan Yoshield Medical Products Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333417
Sponsor-initiated cancellation
Sponsor: 7TH BRAND PTY LTD
Manufacturer: Henan Yadu Industrial Co Ltd
Device/Product name: Public respirator, single-use
ARTG number: 333422
Sponsor-initiated cancellation
Sponsor: Jointown Healthcare Pty Ltd
Manufacturer: Lyncmed Medical Technology (Beijing) Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333423
Sponsor-initiated cancellation
Sponsor: Ironbark Creek Investments
Manufacturer: ANSHUN HEALTH AND MEDICAL TECHNOLOGY CO LTD
Device/Product name: Surgical/medical respirator, single-use
ARTG number: 333424
Sponsor-initiated cancellation
Sponsor: Phone Top Pty Ltd
Manufacturer: Xiantao Tsw Protective Products Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333425
Sponsor-initiated cancellation
Sponsor: Tankya Developing Pty Ltd
Manufacturer: Tankya Developing Pty Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 333426
Sponsor-initiated cancellation
Sponsor: Jointown Healthcare Pty Ltd
Manufacturer: Hubei Safe Way Protective Product Co Ltd
Device/Product name: Surgical/medical respirator, single-use