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Level 3 Surgical Mask with Ear Loops

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The Level 3 Surgical Mask is a single-use face mask for use in healthcare where a person is at risk of blood or fluid splash. Designed to meet Australian Standard AS 4381:2015, the mask limits the passage of blood or body fluids through the mask layers. The Level 3 Surgical Face Mask is TGA Registered.

ARTG 337503

Description & Intended use of the Level 3 Surgical Face Mask
The Level 3 Surgical Face Masks is a single use, non-sterile, surgical Level 3 barrier face mask for use in Healthcare where a person is at risk of blood or fluid splash. Featuring multiple layers of lightweight material, the mask provides comfort and breathability with two ear loops to hold the mask in place.

For USA Only: EUA Application Underway
EUA is currently underway for the Level 3 Surgical Face Masks by US FDA under the Emergency Use Authorisation (EUA) for use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations to prevent wearer exposure to biological airborne particulates during FFR shortage resulting from the COVID-19 outbreak.

Level 3 Surgical Face Mask with Ear Loops

The Level 3 Surgical Mask is a single-use face mask for use in healthcare where a person is at risk of blood or fluid splash. The mask is designed to limit the passage of blood or body fluids through the mask layers.

Featuring multiple layers of lightweight material, the mask provides comfort and breathability with two ear loops to hold the mask in place.

The Level 3 Surgical Mask is available in two ear loop lengths and a head tie option.

The Level 3 Surgical Mask is a single-use face mask for use in healthcare or where a person is at risk of blood or fluid splash. Please see the Level 3 Surgical Mask with Ear Loops Instructions For Use documents below.

Product Specifications

The Level 3 Surgical Mask is designed to meet Australian Standard AS 4381:2015, the mask limits the passage of blood or body fluids through the mask layers.

The Level 3 Surgical Masks is made in Australia using 98%∗ Australian Sourced material.

+ Designed to meet AS 4381:2015 Surgical Face Masks
+ Bacterial Filtration Efficiency (BFE) 98%
+ Differential pressure, mmH2O/cm2 <5.0
+ Resistance to penetration by synthetic blood to 160mmHg
+ Included on the TGA Australian Register of Therapeutic Goods (ARTG)
+ Inner carton dimensions designed for use in vending machines
+ Non-sterile & Latex Free with ear loops

Pending supply availability of critical mask components and material made locally in Australia

Please click to view the Level 3 Surgical Mask Product Technical Sheet

Available Level 3 Surgical Masks

Designed to create the best fit, the Level 3 Surgical Mask with Ear Loops comes in two different earl loop lengths. The Level 3 Surgical Mask is also available with a Head Tie. Please see the Level 3 Surgical Mask with Ear Loops Instructions for Use document below.

Level 3 Surgical Mask with Shortened Ear Loops - W874M

Level 3 Surigcal Mask with Standard Ear Loops - W138M

Level 3 Surgical Mask with Head Ties - W515M

Product Specifications & Documents

Level 3 Surgical Mask with Ear Loops Instructions for Use

Shortened & Standard Ear Loops

Level 3 Surgical Mask with Ear Loops Product Technical Sheet

Shortened & Standard Ear Loops

Respirator & Face Mask Comparison

View Detmold Medical Respirator & Face Mask Comparison table to learn more about the difference between our products. 

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Detmold Medical Pty Ltd  |  ABN 69 639 964 168  |  Part of the Detmold Group  |  45 Chief St Brompton, SA 5007
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