White surgical N95 duckbill respirator with head straps

Respiratory protection

Surgical N95 Respirator, Horizontal Duckbill

Name: Surgical N95 Respirator, Horizontal Duckbill
Brand: Eastwest Medico

Flat-fold particulate respirator with synthetic-blood-resistant surgical clearance – NIOSH N95 approved and FDA cleared as a surgical N95 mask.

NIOSH N95Fluid resistantLatex-free

NIOSH approval

N95 · 42 CFR Part 84

Type

Flat-fold (horizontal duckbill)

Filter efficiency

≥ 95 % (non-oil aerosols)

Exhalation valve

None (valve-free)

Sterility / use

Non-sterile · single use

Shelf life

3 years from manufacture

Request a quote Download datasheet (PDF)

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

Description

The flat-fold answer where a cup respirator will not seal. The horizontal duckbill opens into a breathing chamber away from the mouth, so it stays clear of the lips when speaking and keeps breathing resistance low across a shift.

NIOSH N95 approved under 42 CFR Part 84 and FDA cleared as a surgical N95, passing synthetic blood penetration to ASTM F1862 at 120 mmHg. Non-oil rated, valve-free, latex-free and single use.

A concealed nose clip adjusts individually and the loop headbands are fully adjustable, so the fit can be set rather than accepted. Do not wear one respirator for more than eight hours where filter loading is high.

Flat-foldValve-freeConcealed nose clipAdjustable loop headbandsUrethane foam nosepieceGoggle compatible

Technical data

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

Product identification

NIOSH approval

N95 · 42 CFR Part 84

Type

Filtering facepiece respirator, flat-fold (horizontal duckbill)

NIOSH approval

N95 · 42 CFR Part 84

FDA clearance

FDA cleared – surgical N95

Filter efficiency

≥ 95 % against non-oil aerosols

Exhalation valve

None (valve-free)

Latex

Latex-free – no natural rubber

Sterility / use

Non-sterile · single use

Shelf life

3 years from manufacture

Standards & test performance

Test

Method / standard

Result

Particle filtration efficiency

42 CFR Part 84 (N95)

≥ 95 % – non-oil aerosols

Synthetic blood penetration

ASTM F1862

Pass at 120 mmHg

Flammability

16 CFR Part 1610

Class 1 (≥ 3.5 s)

Biocompatibility

ISO 10993

Pass

Materials in contact: head strap, urethane nose foam, plastic nosepiece and filter media – all latex-free and free of natural rubber.

Intended use

Respiratory protection against non-oil airborne particulate aerosols – e.g. mining, sanding, grinding and drilling – and against allergens, bacteria, viruses and tuberculosis. The surgical N95 clearance adds synthetic-blood resistance for healthcare workers during occupational exposures such as influenza outbreaks. Time-use restrictions may apply.

Packaging

Inner box

20 respirators · 215 × 100 × 195 mm

Master carton

480 respirators (24 boxes × 20)

Carton size

880 × 320 × 410 mm · FOSC, BC double-wall

Storage

−5 °C to +50 °C · RH < 75 %

Service time limitation

– Do not use one respirator for more than 8 hours (continuous or intermittent) where high filter loading may occur.

– Leave the contaminated area and discard the respirator if breathing becomes difficult, a proper fit cannot be obtained, or it is damaged, soiled or distorted.

– Maximum service time is five (5) consecutive calendar days (including days of non-use) from first use.

Warnings

– Read the fitting instructions and use limitations before use.

– This respirator does not guarantee protection against contracting disease or infection.

– Occupational use requires a written respiratory-protection program meeting local requirements; in the US, OSHA 29 CFR 1910.134 (medical evaluation, training and fit testing).

Quality management

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

Respiratory standard

NIOSH N95 approved under 42 CFR Part 84 – .

Regulatory clearance

FDA FDA cleared – cleared for use as a surgical N95 mask.

Barrier testing

Synthetic blood penetration pass at 120 mmHg (ASTM F1862); flammability Class 1 (16 CFR Part 1610).

Biocompatibility

ISO 10993 – pass.

Latex

Latex-free – all contact materials free of natural rubber.

Occupational use

Requires a written respiratory-protection program; in the US, OSHA 29 CFR 1910.134 (medical evaluation, training and fit testing).

NIOSH N95Fluid resistantLatex-free

Ordering

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

Item

Product number

Pack

Surgical N95 respirator, inner box

EW-N95-DB-01

20 pcs

Surgical N95 respirator, master carton

EW-N95-DB-01-MC

480 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.

Technical datasheet

PDF · DS- rev. 1.0 · Jul 2026

Available on request

NIOSH approval certificateFDA 510(k) clearanceASTM F1862 test reportFitting instructionsISO certificates (manufacturer)

Request documentationSigned sets issued for tender submission, normally within two working days.