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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 26 - 50 of 712
ARTG number: 236259
Sponsor-initiated cancellation
Sponsor: Cause Im Happy
Manufacturer: Xiantao Juenya Medical Products Co Ltd
Device/Product name: Mask, <specify>
ARTG number: 259931
Sponsor-initiated cancellation
Sponsor: Plus Medical Pty Ltd
Manufacturer: Foshan Nanhai Plus Medical Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 266930
Sponsor-initiated cancellation
Sponsor: Mun Australia Pty Ltd
Manufacturer: Thai Hospotal Products Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 282561
Sponsor-initiated cancellation
Sponsor: Australian Safety Wholesalers Pty Ltd
Manufacturer: Australian Safety Wholesalers Pty Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 283635
Sponsor-initiated cancellation
Sponsor: Bunzl Australia
Manufacturer: HUBEI XINYUAN Safety Protective Products Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 285138
Sponsor-initiated cancellation
Sponsor: Mun Australia Pty Ltd
Manufacturer: Master and Frank Enterprise Co Ltd
Device/Product name: Surgical/medical respirator, single-use
ARTG number: 286752
Sponsor-initiated cancellation
Sponsor: PERTH DENTAL SUPPLIES PTY LTD
Manufacturer: Tribest Dental Products Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 294412
Sponsor-initiated cancellation
Sponsor: Gunz Dental Pty Ltd
Manufacturer: AR Medicom Inc
Device/Product name: Mask, surgical, single use
ARTG number: 298741
Sponsor-initiated cancellation
Sponsor: Healthware Aus Pty Ltd
Manufacturer: Mydent International
Device/Product name: Mask, surgical, single use
ARTG number: 299583
Sponsor-initiated cancellation
Sponsor: Kimberly-Clark Australia Pty Ltd Professional Division
Manufacturer: Halyard Health Inc
Device/Product name: Mask, surgical, single use
ARTG number: 299907
Sponsor-initiated cancellation
Sponsor: Proline Medical Pty Ltd
Manufacturer: Hubei Haixin Protective Products Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 302725
Sponsor-initiated cancellation
Sponsor: LWJ Corporation Pty Ltd
Manufacturer: Anqing Kangmingna Packaging Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 305207
Sponsor-initiated cancellation
Sponsor: Medi-Dent Pty Ltd
Manufacturer: Shanghai Dochem Industries Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 305352
Sponsor-initiated cancellation
Sponsor: P & T Importing Pty Ltd
Manufacturer: Tribest Dental Products Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 306238
Sponsor-initiated cancellation
Sponsor: Linear Medical Pty Ltd
Manufacturer: Linear Healthcare Group
Device/Product name: Mask, surgical, single use
ARTG number: 306285
Sponsor-initiated cancellation
Sponsor: Grace Global Pty Ltd
Manufacturer: Guangzhou Jaan Medical Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 308620
Sponsor-initiated cancellation
Sponsor: Omni-Tel Pty Ltd
Manufacturer: Xiantao Tsw Protective Products Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 312295
Sponsor-initiated cancellation
Sponsor: Mun Australia Pty Ltd
Manufacturer: Mun Global Sdn Bhd
Device/Product name: Surgical/medical respirator, single-use
ARTG number: 326271
Sponsor-initiated cancellation
Sponsor: KK Dental Pty Ltd
Manufacturer: Shanghai Lion Dental Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 330610
Sponsor-initiated cancellation
Sponsor: Henry Schein Halas
Manufacturer: Young Dental Manufacturing Co 1 LLC
Device/Product name: Mask, surgical, single use
ARTG number: 331161
Sponsor-initiated cancellation
Sponsor: Henry Schein Halas
Manufacturer: Salute IND e COM de PROD MAN LTDA
Device/Product name: Mask, surgical, single use
ARTG number: 331302
Sponsor-initiated cancellation
Sponsor: First Global Australia Pty Ltd
Manufacturer: Xiantao Sanda Industrial Co Ltd
Device/Product name: Mask, surgical, single use
ARTG number: 331304
Sponsor-initiated cancellation
Sponsor: Integrity Hospital Supplies Pty Ltd
Manufacturer: DMC OZEL SAGLIK HIZ TH IHR SAN ve TIC LTD STI
Device/Product name: Surgical/medical respirator, single-use
ARTG number: 331425
Sponsor-initiated cancellation
Sponsor: AUSTRALIAN BUSINESS MOBILES (NSW) PTY LTD
Manufacturer: GREENBY BAGS
Device/Product name: Mask, surgical, single use
ARTG number: 331608
Sponsor-initiated cancellation
Sponsor: Perios Pty Ltd
Manufacturer: Changzhou Shuangma Medical Devices Co Ltd
Device/Product name: Mask, <specify>