SURGICAL MASKS Type IIR Mask
. Non-woven fabric Polypropylene in 3 protective layers;
. Nose adjustment and ear support elastic bands;
. Pleats for adaptation to the user's face;
. Biocompatible and latex-free;
. Adult and child sizes;
. High bacterial and particle filtration;
. Highly breathable;
. Splash resistance (Type IIR);
. Fabricated in clean room (ISO 14644 â?? 1:2015);
This disposable medical mask is made of polypropylene non-woven cloth, melt spraying cloth, elastic ear band and bridge of nose strip. It is non-sterile.
With CE certification
With EN14683 certification
Packed by 50 pieces in one box
Filtration rate of 98%
Tested by SGS
Successfully delivered to several hospitals and to the Dutch government
General Features
Size: 17.5 x 9.5cm
Colour: Blue and white
Materials: polypropylene, non-woven fabric
Packaging: 50 masks per box
Safety Features
CE certified
In accordance with the European standard EN14683:2005
BFE 98%
The middle polypropylene layer filters airborne particulate matter
Water-absorbent inner layer to alleviate the moisture build-up
Water-repellent outer layer to prevent inhalation of even smaller liquid droplets
Splash-resistant ( 120 mmHg)
Comfort Features
Breathing resistance 49 Pa/cm2
The soft material makes the mask-wearing more comfortable
A non-irritating inner layer
Adjustable nose clip for a better fit
Elastic ear loops for a more secure mask adjustment
3 layers
Our 3-ply Type II R face masks have a multi-ply design to better prevent inhalation of non-oily airborne pollutants and penetration of bodily fluids. The blue outer layer and white inner layer are made out of non-woven materials, with a polypropylene filtration layer in the middle. The non-woven layers are designed to provide a comfortable fit, with the protective melt-blown middle layer serving as the barrier.
Bacteria filter efficiency (BFE)
Our Type II R medical masks effectively resist bacterial penetration with a rating of at least 98% in accordance with the European standard. Therefore, you can go about your business, knowing that you are 98- 99.9% protected from inhaling airborne pollutants or hazardous splatter.
100% compliant with regulations (CE, EN14683:2005)
Our 3-ply surgical masks are 100% CE certified. They are also in accordance with the European standard EN14683:2005. Please note that if you need reassurance regarding the certification of our products, we are willing to send you the copies of the relevant documents upon request!
Splash resistance
The unique feature of Type II R surgical masks is the liquid-repellent layer offering additional protection against particulate matter and infectious splashes. The greater protective efficiency of the masks adequately makes up for the higher breathing resistance (49 Pa/cm2).
Disposable
In order for your Type II R mask to effectively protect you from the pollutants you should wear it for a maximum of four to five hours. Please do not share your 3-ply face mask with other people. If your mask becomes damaged or dirty, throw it away. Please follow the World Health Organisation's (WHO) guidelines for correctly putting the mask on and off.
Type IIR 98% BFE against splashes, fluid-resistant Respirators. High-quality splash and droplet resistant 3-ply Medical Face Mask, governments recommended with one of the highest bacterial filtration efficiency (BFE) which exceeding 98% for additional safety. Surgical Mask are big volume on sales for hospitals in Europe and fully recommended. Easy to breathe through and non-irritating skin-friendly and hypoallergenic inner layer, and 3S outer type layer. Flexible and comfortable.
Type IIR 98% BFE against splashes, fluid-resistant Respirators. High-quality splash and droplet resistant 3-ply Medical Face Mask, governments recommended with one of the highest bacterial filtration efficiency (BFE) which exceeding 98% for additional safety. Surgical Mask are big volume on sales for hospitals in Europe and fully recommended. Easy to breathe through and non-irritating skin-friendly and hypoallergenic inner layer, and 3S outer type layer. Flexible and comfortable.
CE certified
Complies with EN 14683 : 2019 Standard
In accordance with the Medical Devices Directive 93/42/ EEC and EU Regulation 2017/745.
Bacterial filtration efficiency BFE > 98%
3-layer hypoallergenic non-woven material construction
Splash resistant
17.3 x 9.5 cm (universal size)
The mask has an integrated adjustable nose wire and soft comfortable ear loop
Light, soft, and skin friendly
Does not obstruct breathing
Single use mask
We provide an unique combination of opposites: the highest bacterial filtration efficiency (BFE 99.9%) and fluid penetration resistance (type IIR)
with easy breathability (low airflow resistance).
Description briefly
Certified Medical Masks in the highest possible group for this type of mask - Medical Mask Type IIR (class I, rule 1) / EN 14683: 2019 + AC: 2019 /
Bacterial Filtration Efficiency BFE 99% (BFE min 99,89% in report tests) / EN 14683: 2019 + AC: 2019 /
Blood splash tests - resistance to the penetration of synthetic blood (body fluids, ...) / ISO 22609: 2004 /
Complete tests in European accredited laboratories / LAB N�° 1827 L, 1289 / LE2439 / - full detailed test reports for sharing if necessary
The best raw materials â?? we tested many certified kinds of raw materials from all over Europe â?? we have selected the best of them (under permanent quality monitoring of raw materials, test reports, certificates)
Masks are packed: 50 pcs. in box and additionally 10 pcs. in translucent foil/film to ensure and maintain biological cleanliness (collective packaging: 1200 pcs) CE (medical device)
Fully automatic production at the Rezal plant guaranties repeatable high quality. Additionally each mask has separately folded ear loops inside the mask (hygiene aspect, convenience of unpacking / using)
Our Face mask are recommended For health Care personnel and the
general public to prevent the spread of infection or illness This face
mask is fluid â?? resistant and is designed to use in surgical setting to
protect against living organisms such as bacteria , Fungi and Large
droplets, splashes , or other hazardous fluids.
The masks are of a 3-layer construction comprising two
layers of high-quality spun bond material with a smooth surface finish which covers one layer of outstanding performance non woven special filter and melt blown filter material that is electrostatically charged. The electrostatic element attracts and then traps the tiniest of particulate whilst remaining easy to breathe through.
The product is skin friendly and allergy free.
* Protection for people and workers who place great value on facial expressions such as children, people with hearing problems, police forces and nurses, The mask can be used also as non-sterile mask in hospitals and vaccine centres. No fogging of glasses thanks to extra soft nose pads.
* Colour: Black and white
* Size: Standard and children
* Box: 50 pieces
* Price per box: CHF 53.75
* Languages: Italian, French, German,
* Brand: ST-Cleantech AG
* English, and Spanish
First layer non-woven: White or Black: 50g (double S)
Second layer: 25g melting spray cloth
Third layer non-woven: White or Black: 25g (double S)
Layer 4 PP transparent sheet:
Thickness: 0.33mm +/- 0.1mm
Size: 134mm x 37mm +/- 2mm
Material: PP
Classification /Standard:
Medical device: Class I / according to DIN EN14683:2019.
Duration: 2 years
Material: Consisting of: non-woven fleece layer PP, filter material PP manufactured in meltblown process, PP window (13.4x3.7x0.2 cm) ultrasonically
welded latex-free, nose clip, aluminium wire PE coated, ear bands made
of elastane.
Level of performance:
Filter efficiency
antibacterial : (BFE)
Respiratory resistance : Resistance to pressure spray:
Microbiological purity :
According to type IIR (same test standard to be applied).
Norm: 98% - Test result: 99.9%.
(according to EN 14683:2019+AC:2019, Annex B).
Standard: <60 (pa-m) - Test result: <59.7 (pa-m) /
Flow rate: 8l/min.
(according to EN 14683:2019+AC:2019, Annex C).
Standard: 16 kPa - Test result: <21.3 (kPa) / AQL
4.0%, the highest corresponding blood pressure
(according to ISO 22609:2004)
Standard: <30 cfu/g - Test result: Average of 5 samples: 12.80 cfu/g
(according to EN 14683:2019+AC:2019, Annex C)
Dimensions mask : 17.5 x 9.5 cm x 2 mm
Packaging type: 50 pieces in transparent film
Brand Name : SHM
China Medical Approved List :
Product : Type IIR Disposable Mask (non-sterile)
BFE (Bacterial Filtration Efficiency) : 98%
Product Certification : CE Marked
Factory Certification : EN ISO 13485:2016
Manufacturing Standard : EN 14683:2019
Product Material : Nonwoven 3ply, splash resistant
Manufactured to EN
14683:2019 standards
Splash Resistant to â?¥16kPa
(120mmhg)
Differential Pressure <60
(tested 13-15)
Designed for a close fit over the nose, mouth and chin
Each inner pack contains 10 masks
Each inner box contains 5 packs
40 inner boxes per carton
2,000 masks per carton
FDA registration. CE certificate. Test report.
OTG USA. Ready to ship. Inspect & Pay supported!
1. New fabric PP non-woven fabric, soft and clear, comfortable and breathable
2. Seamless binding process
3. Three fold design, more breathing space on the face
4. Plastic nose strip, aluminum-plastic nose strip,
5. Multi layer protection for your respiratory health
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