Earloop Surgical
Face Mask
3 Layer
High Filtering
Bacterial Filtration Efficiency 98.43
Anti-Droplets
Comfortable & Breathable
Three Layer Design
Blocking Dust
Durable Water Repellency
Adjustable Nose Bridge
Skin Friendly
Anti Microbial
Earloop Surgical Face Mask
3 Layer High Filtering
High filteration efficency for protection in many environments
DATA SHEET
Intended Use
The procedure masks are intended to be worn by personnel during surgical or other medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer.
- Low resistance to breathing
- Hypoallergenic
- Non-Irritating
- Latex Free
- Easy to use
- From Fit Design
Applied Standards
Test
Medical face mask – Requirements and test methods
Method
EN14683+AC 2019
Specimen
Medical and surgical mask
Result
Pass – TYPE IIR
Our face mask passed EN 14683+AC test method as TYPE IIR
Lab Test Results
Bacterial Filtration Efficiency (BFE)
BFE @ 3.0 µm large Bacteria ≥ 98%
Differential Pressure (∆P)
∆P < 5.0 mm of H2O/cm2
Particulate Filtration Efficiency (PFE)
PFE @ 0.1 µm large Latex particules ≥ 98%
Fluid Resistance
Synthetic Blood Resistant @ 120mmHg
Flame Spread
Class I
Technical Data Sheet
Spunbond Polypropylene (SBPP)
20 gr
Meltblown Polypropylene (MBPP)
25 gr
Elastic Band Composition
Knitted Polyester
Spunbond Polypropylene (SBPP)
30gr
Nose-piece Composition
Aluminum / Plastic covered iron
CE Certificate
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
Technical Data Sheet
Rectangular face masks with a shapeable nosepiece and two earlobes present, one on each side, in order to hold mask in place.
Length
175 mm
Nosepiece Length
80 mm
Pleat Depth
10 mm
Width
95 mm
Earloop Length
200 mm
ISO Certificate
ISO 9001 is the international standard for a quality management system (“QMS”). The standard is used by organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements and to demonstrate continuous improvement.
ISO 13485
ISO 9001
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