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Blue three-ply Type IIR disposable surgical mask with ear loops
Respiratory protection

Type IIR Disposable Surgical Mask

3-ply pleated surgical mask certified to EN 14683:2019+AC:2019 Type IIR – ≥ 98 % filtration with splash resistance.

EN 14683 Type IIRMDR 2017/745ISO 13485
Sizes
One size fits most
Colour
Blue
Filtering efficiency
≥ 98 %
Differential pressure
< 60 Pa/cm²
Sterility
Non-sterile
Shelf life
2 years
Request a quoteDownload datasheet (PDF)

Supplied on tender, framework agreement and humanitarian programme terms. Sample cartons available for evaluation.

Description

Type IIR is the tier that adds splash resistance, and that is the reason to specify it. Under EN 14683 a Type II mask needs only ≥ 98 % bacterial filtration; Type IIR adds a pass at ≥ 16.0 kPa, which is what matters at the bedside and in any procedure that can spray.

Differential pressure stays below 60 Pa/cm², so the added barrier does not cost breathability over a long wear. Three-ply construction with an adjustable nose clip and ear loops, fitted without tying.

Inner and outer faces are colour-identified, blue out, so a mask worn the wrong way round is visible across a room. Class I medical device under MDR 2017/745, latex-free, supplied non-sterile.

3-ply constructionEar loopsAdjustable nosepieceLow profileLatex-freeSingle use
Technical data

Data as declared by the manufacturer and verified in our own quality review. Full test reports available on request.

Product data
Sizes
One size fits all
Compliance
Medical device Class I (MDR 2017/745)
EN 14683 Type IIR (CE)
Filtering efficiency (BFE)
≥ 98 %
Splash resistance
Pass at ≥ 16.0 kPa
Differential pressure
< 60 Pa/cm²
Microbial cleanliness
≤ 30 cfu/g
Biocompatibility (ISO 10993)
Pass
Colour
Blue
Sterility
Non-sterile
Latex status
Not made with natural rubber latex
Shelf life
2 years
Manufacturer QMS
ISO 13485, ISO 9001
EN 14683:2019 barrier levelsRange comparison
Parameter
Type I
Type II
Type IIR
BFE %
≥ 95
≥ 98
≥ 98
Splash resistance
Not required
Not required
Pass ≥ 16.0 kPa
Differential pressure
< 40 Pa/cm²
< 60 Pa/cm²
< 60 Pa/cm²
Microbial cleanliness
≤ 30 cfu/g
≤ 30 cfu/g
≤ 30 cfu/g
Fitting instructions
1. Position the mask with the nosepiece on top, blue (hydrophobic) layer facing out.
2. Gently stretch the straps and loop behind both ears.
3. Pull the pleats down to cover the chin.
4. Press the nosepiece towards the nose to ensure a proper seal.
Packaging50 pcs/box · 40 boxes/carton
Carton L
W
H
Box L
W
H
Total
52.0
38.0
34.0
18.0
10.0
8.0
2 000 pcs
Quality management

Every batch is inspected by our own team in Asia and independently verified by SGS or TÜV before shipment.

Product standard
EN 14683:2019+AC:2019 Type IIR – bacterial filtration efficiency ≥ 98 % with splash resistance.
Regulatory
Medical device, Class I, in accordance with MDR 2017/745.
Notified body
CIBG notification 20211054 ().
Biocompatibility
Evaluation completed according to ISO 10993.
Manufacturer QMS
ISO 13485, ISO 9001.
EN 14683 Type IIRMDR 2017/745ISO 13485
Ordering

Product numbers for reordering and framework call-offs. Private-label and custom packaging available on volume.

Item
Product number
Pack
Disposable 3-layer procedure ear-loop face mask
EW-MSK-IIR-01
2 000 pcs
Documents

The technical datasheet and declaration of conformity are available to download. All further documentation is issued on request, signed and current, for tender submission.

Available on request
EN 14683 test reportBiocompatibility evaluationISO certificates (manufacturer)
Request documentationSigned sets issued for tender submission, normally within two working days.

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