S0305135

Mask,surgic,typeIIR,tiestrap,disp.pack50


Mask,surgic,typeIIR,tiestrap,disp.pack50
Indicative Price 2.56 USD
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General description:
Mask,surgic,typeIIR,tiestrap,disp., pack of 50

Intended Use:
A mask intended for medical purposes that covers the user's nose and mouth and provides a physical barrier to fluids.

Technical specifications:
. Splash resistant, type IIR surgical mask
. Bacterial filtering efficiency: equal to or greater than 98%
. Breathing resistance: equal to or less than 49 Pa/cm2
. Splash resistance pressure: greater than 120 mmHg
. Fabric, non-woven with outer layer impervious liquid splash resistant material, f.e. polyethylene
. Comprised of 3 or 4 non-woven layers, size adequately covering nose, mouth and chin
. Clearly identifiable inner and outer surfaces
. With attached 2 x 2 tie-straps, allowing correct fixation and securing at the back of the head
. Size: 15-19 cm x 9-11 cm (l x w)
. Non-sterile
. Single use, disposable

Quality Management System:
ISO 13485:2016: Medical devices - Quality management systems

Regulation & classification:
Medical Device Regulation (EU) 2017/745, Class I
Medical Device Directive 93/42/EEC, Class I
(or equivalent internationally recognised marketing clearance)

Compliance to safety & product performance standards:
Compliant with the EN 14683 standard for type IIR (or equivalent international standard)

Packaging and labelling:
Primary packaging 50 units

Labelling on primary packaging must include:
- Name and/or trademark of the manufacturer
- Manufacturer's product reference
- Type of product and main characteristics
- If the packaging is not transparent, it must bear a diagram (preferably actual size) showing the essential parts of the product and indicating the position of the product in the packaging
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol)
- Information for handling, if applicable (or equivalent harmonised symbol)
Over packaging: Packaging unit
Labelling on the packaging unit: Labelling to be the same as primary packaging.
Extra information required: Number of units per box.

Weight: 2.18 kg
Volume: 0.03 0m3
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