Medical Masks – AS Level 2 & ASTM Level 2

$38.00 inc. GST

The Level 2 Medical Mask with ear loops is a single-use face mask for use in healthcare where a person is at risk of blood or fluid splash. Certified to meet Australian Standard AS 4381:2015, the mask limits 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.

800 in stock (can be backordered)

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SKU: NWPL2MSK50 Category:

Description

Product Information


The Level 2 Medical Mask with ear loops is a single-use face mask for use in healthcare where a person is at risk of blood or fluid splash. Certified to meet Australian Standard AS 4381:2015, the mask limits the passage of blood or body fluids through the mask layers. Featuring multiple layers of lightweight material, the mask provides comfort and breath-ability with two ear loops or horizontal ties to hold the mask in place.

APPLICATIONS: For use in emergency departments, dentistry, changing dressings on small or healing wounds where minimal blood droplet exposure may possibly occur (e.g. endoscopy procedures

  • Ear Loops
  • Certified to meet AS 4381: 2015 & ASTM F2100-19e1 Medical Face Masks
  • Bacterial Filtration Efficiency (BFE) 98%
  • Differential pressure, mmH2O/cm2 <5.0
  • Resistance to penetration by synthetic blood to 120mmHg
  • Included on the TGA Australian Register of Therapeutic Goods (ARTG) from September 2020
  • CE and FDA certifications
  • Non-sterile & Latex Free with ear loops

Testing Standards


Characteristics Testing Criteria Testing Method Test Facility
Bacterial Filtration Efficiency % (BFE) 98% ASTM F2101 NELSON LAB
Differential Pressure, mmH2O/cm2 <5.0 AS 4381:2015, EN 14683:2014 Annex C VIC LAB
Resistance to penetration by synthetic
blood, minimum pressure in mmHg, pass result
160mmHg AS 4381:2015; ISO 22609 or ASTM
F1862/F1862M-13
VIC LAB

Nallawilli Protect Masks – Performance Levels


M A S K    P E R F O R M A N C E     L E V E L S
ASTM LEVEL 3 Non Sterile/Sterile disposable
3 Ply, Non Woven, with ear loops and or horizontal tie
BFE > 99%, PFE > 99% and > 99%
Filtration of bacteria, dust and pollen
LEVEL 3
ASTM LEVEL 2 Non Sterile/Sterile disposable
3 Ply, Non Woven with ear loops and or horizontal tie
BFE 98%, PFE 98% and >99%
Filtration of bacteria, dust and pollen
LEVEL 2
ASTM LEVEL 1 Non Sterile/Sterile disposable
3 Ply, Non Woven with ear loops and or horizontal tie
BFE 95%, PFE 95% and >99%
Filtration of bacteria, dust and pollen
LEVEL 1

Nallawilli Protect Masks – Additional Information


A D D I T I O N A L    I N F O R M A T I O N
Nallawilli Protect Medical Mask – Level 2 Click Here
Certificate Matrix Click Here
Nallawilli TGA Certificate Click Here
BMP 731192 Certificate and Schedule Click Here
Test Summary Click Here

TGA Registration


Inclusion on the TGA Australian Register of Therapeutic Goods (ARTG) – from September 2020
TCG single-use PPE masks have been designed for therapeutic use, as they are intended to reduce or prevent the transmission of disease or micro-organisms which meet the definition of a medical device. Medical device products are regulated by the TGA under the Therapeutic Goods Act 1989. Before supply in Australia, these goods need to be included on the ARTG.

To meet the requirements for inclusion on the Register, TCG must meet requirements for product quality, safety and performance in accordance with Australian or international standard requirements. This pre-market data is provided for assessment, and market authorisation is then granted to allow entry of the therapeutic goods to the ARTG.

 

Additional information

Weight .250 kg
Dimensions 21 × 10 × 9.5 cm
Packaging

Box

Per Box

50 Masks

Per Carton

40 Boxes / 2000 Masks

Type

Medical Mask

Size

One size fits all

Construction

Disposable 3 Ply

Holder

Ear Loop

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