Eastwest MedicoContact sales
Blue FFP2 surgical N95 disposable respirator, three-panel fold
Respiratory protection

FFP2 / Surgical N95 Disposable Respirator

Double certified to NIOSH Surgical N95, EU FFP2 and EN 14683 Type IIR – foldable 3-panel design with fluid resistance.

FFP2NIOSH N95EN 14683 Type IIRFDAMDR 2017/745
Sizes
One size fits all
Colour
Blue
Filtering efficiency
≥ 98 %
NIOSH approval
Surgical N95
Sterility
Non-sterile
Shelf life
5 years
Request a quoteDownload datasheet (PDF)

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

Description

One respirator that satisfies both the European and the American protocol. It is certified to EU FFP2, to NIOSH Surgical N95 and to EN 14683 Type IIR at the same time, which matters for programmes that ship across both jurisdictions and would otherwise stock two respirators and reconcile two sets of paperwork.

Filtering efficiency is at least 98 %, and it passes synthetic blood penetration to ASTM F1862 at 160 mmHg, which is what the surgical clearance rests on. Valve-free, so exhaled air is filtered too.

The three-panel fold gives a larger filtering area than a moulded cup and packs flat. High-density nose foam and TPE head straps hold the seal without loading the nose bridge, and each respirator is individually packed.

Foldable 3-panelTPE head strapsHigh-density nose foamAdjustable nose clipValve-freeIndividually packed
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)
NIOSH
FDA
FFP2
EN 14683 Type IIR (CE)
NIOSH TC-number
Filtering efficiency
≥ 98 %
Synthetic blood penetration (ASTM F1862)
Pass at 160 mmHg
Flammability (16 CFR Part 1610)
Class 1 (≥ 3.5 seconds)
Splash resistance
Pass at ≥ 16.0 kPa
Differential pressure
< 60 Pa/cm²
Microbial cleanliness
≤ 30 cfu/g
Biocompatibility (ISO 10993)
Pass
Colour / sterility
Blue · non-sterile
Latex status
Not made with natural rubber latex
Shelf life
5 years
Manufacturer QMS
ISO 13485, ISO 9001
Fitting instructions
1. Hold the mask in your hand with the nosepiece at your fingertips, headbands hanging freely below your hand.
2. Place the mask under your chin with the nosepiece up. Pull the top headband over your head and above the ears.
3. Pull the bottom headband over your head and place around the neck below the ears.
4. Adjust the headbands for a comfortable fit. Push the nosepiece inward to conform to the shape of your nose.
5. Cup both hands over the mask and inhale sharply – negative pressure should be felt inside. Re-adjust as necessary.
Packaging20 pcs/box · 20 boxes/carton
Carton L
W
H
Box L
W
H
Total
51.0
49.5
36.0
24.5
9.5
17.0
400 pcs
Quality management

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

Respiratory standards
NIOSH Surgical N95 () and EU FFP2; EN 14683 Type IIR as a medical face mask.
Barrier testing
Synthetic blood penetration pass at 160 mmHg (ASTM F1862); splash resistance pass at ≥ 16.0 kPa.
Breathability
Differential pressure < 60 Pa/cm² at filtering efficiency ≥ 98 %.
Biocompatibility
ISO 10993 – pass. Microbial cleanliness ≤ 30 cfu/g.
Regulatory
Medical device, Class I, in accordance with MDR 2017/745. FDA requirements met. Manufacturer QMS: ISO 13485, ISO 9001.
FFP2NIOSH N95EN 14683 Type IIRFDAMDR 2017/745
Ordering

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

Item
Product number
Pack
FFP2 / surgical N95 disposable respirator
EW-FFP2-N95-01
400 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
NIOSH approval certificateEN 14683 Type IIR test reportASTM F1862 test reportFitting instructionsISO certificates (manufacturer)
Request documentationSigned sets issued for tender submission, normally within two working days.

Related products

Full product range →
White N95 disposable respirator with vertical fold and yellow head straps
Respiratory protection
N95 Disposable Respirator, Vertical Fold
White surgical N95 duckbill respirator with head straps
Respiratory protection
Surgical N95 Respirator, Horizontal Duckbill
Blue three-ply Type IIR disposable surgical mask with ear loops
Respiratory protection
Type IIR Disposable Surgical Mask
Blue powder-free nitrile examination glove worn on a hand
Examination gloves
Nitrile Examination Gloves

Need this product specified into a tender?

Our team supplies technical documentation, sample cartons and delivery schedules for institutional buyers.

Contact our teamRequest samples