FIX MASK

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

For purchasing requests and your questions

Contact us for inquiries