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Testing of face masks and respirators

TGA Laboratories testing report

21 May 2021

Background

COVID-19 has caused a rapid rise in demand for the manufacturing, importation and sale of face masks and respirators, and there has been an associated increase in medical device inclusions in the Australian Register of Therapeutic Goods (ARTG). There has also been a growth in concerns regarding the quality and performance of these kinds of devices.

The TGA Laboratories has developed capabilities to test surgical masks and respirators, to assess compliance with the requirements of key performance criteria. This testing, in conjunction with the Post-market Review of face masks, will provide the Australian community with information about the suitability of available face masks and respirators.

More information about different types of face masks and respirators has been published on the TGA website:

Testing

The TGA Laboratories is conducting an assessment of the compliance of face masks and respirators included on the ARTG[1] as well as those supplied to the National Medical Stockpile under the Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020. The masks and respirators in the National Medical Stockpile will be prioritised within our testing plan.

The TGA Laboratories, guided by the relevant Standards, is examining the following attributes of face masks and respirators:

  1. Visual Inspection - a visual and physical examination of labelling, design and construction quality
  2. Fluid Resistance[2] - testing of the ability to provide a barrier against penetration by blood and/or other body fluids

    NOTE: For face-masks and surgical respirators with major areas where the material or thickness varies, each of these areas is tested for fluid resistance e.g. we target seams, logos and lines if present in the main body of the mask.

  3. Particle Filtration - testing of the ability to filter out small, aerosolised particles
  4. Sterility - where a face product claims to be provided in a sterile state, this will be tested.

TGA testing is targeted at assessing a few key performance parameters for masks and respirators. This does not replace the manufacturer’s obligation to have their products appropriately tested to demonstrate compliance with the essential principles for medical devices and any claimed standards on their labelling or application for ARTG inclusion.

The results of TGA laboratory testing will be made available on this page, and updated regularly. Please note that the information posted here is correct at the time of publication, and should be considered as preliminary results of what the TGA have tested against and released to date. These may be updated as more information becomes available[3].

Where only labelling deficiencies are identified, the TGA is working with sponsors to resolve the issues without unnecessarily removing products from the market, where practical.

TGA laboratory testing can only verify the performance of devices in relation to the tests we have applied. There may be products that are found to be compliant based on TGA laboratory testing, that do not comply with other regulatory requirements.

In the event a product is found non-compliant or testing results are in dispute (other than labelling deficiencies) the Sponsor is instructed to quarantine the affected products. Whilst the product is quarantined, the TGA together with the Sponsor and Manufacturer; undertake further investigation of the matter to determine what actions are appropriate.

The testing results below should be considered along with information published by the TGA about:

Footnotes

For more information about face masks visit Face masks and COVID-19.

Testing results

Displaying 51 - 62 of 62

Enter an ARTG number, sponsor, manufacturer, label name or batch number

ARTG number: 337503

Mask type: Surgical mask

Batch number: 79052003

Sponsor: Detmold Medical Pty Ltd

Manufacturer: Detmold Medical Pty Ltd

Label name: Detmold Medical Level 3 Surgical Masks

Results:

  • Visual inspection: Compliant
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 337503

Mask type: Surgical mask

Batch number: 79052001

Sponsor: Detmold Medical Pty Ltd

Manufacturer: Detmold Medical Pty Ltd

Label name: Detmold Medical Level 3 Surgical Masks

Results:

  • Visual inspection: Compliant
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 338150

Mask type: Surgical mask

Batch number: 2020070101

Sponsor: King International Operations Pty Ltd

Manufacturer: Hunan Runfuxiang Clothing Co Ltd

Label name: RUNFUXIANG KING INTERNATIONAL - SURGICAL FACE MASK (SINGLE USE) - MEDICAL DEVICE CLASS 1

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 338331

Mask type: Surgical mask

Batch number: N/A

Sponsor: Vicki Partridge Pty Ltd

Manufacturer: HELONG OUZHAN GARMENTS CO LTD

Label name: Cole Workwear Level 2 Surgical mask

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 339255

Mask type: Surgical mask

Batch number: 240820

Sponsor: Care Essentials Pty Ltd

Manufacturer: Care Essentials Pty Ltd

Label name: Cocoon Surgical Face masks

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 340020

Mask type: Surgical mask

Batch number: 20200727

Sponsor: Simba Textile Mills Pty Ltd

Manufacturer: BM Medical Technology Co Ltd

Label name: Single Use Face Mask

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 340305

Mask type: Surgical mask

Batch number: P302458

Sponsor: PRIVATE BRANDS PTY LTD

Manufacturer: Crown Name (WH) United Co Ltd

Label name: WORX SERIES Surgical Mask Type II R

Results:

  • Visual inspection: Compliant
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 340518

Mask type: Surgical respirator

Batch number: N-030820

Sponsor: Care Essentials Pty Ltd

Manufacturer: Care Essentials Pty Ltd

Label name: Cocoon N95 Face Masks Model MSK-001

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: Compliant
  • Sterility: N/A

ARTG number: 340768

Mask type: Surgical mask

Batch number: 200715

Sponsor: Promedica Pty Ltd

Manufacturer: ANSHUN HEALTH AND MEDICAL TECHNOLOGY CO LTD

Label name: Chu Tian De Ming Medical Face Masks

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 340827

Mask type: Surgical mask

Batch number: 20200803

Sponsor: The Trustee for Luca Ferrari Trust

Manufacturer: 5R MED Instruments (Chengdu) Co Ltd

Label name: Medical Face Mask EN 14683:2009+AC:2019 Type I, ASTM F 2100-11 Level 1 (non sterile) Bacterial Filtration Efficiency (BFE) >95%

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 340872

Mask type: Surgical mask

Batch number: 200715

Sponsor: COWISE GROUP PTY LTD

Manufacturer: BJZHF Panther Medical Equipment Co Ltd

Label name: Surgical Face Masks (non-sterile)

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: N/A
  • Sterility: N/A

ARTG number: 344036

Mask type: Surgical respirator

Batch number: 011120

Sponsor: An Lanh Australia Pty Ltd

Manufacturer: An Lanh Investment and Trading Company Limited

Label name: Medical Face Mask (AN95) (76480)

Results:

  • Visual inspection: Label deficiencies
  • Fluid resistance: Compliant
  • Particle filtration: Compliant
  • Sterility: Non-compliant

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