White N95 disposable respirator with vertical fold and yellow head straps

Respiratory protection

N95 Disposable Respirator, Vertical Fold

Name: N95 Disposable Respirator, Vertical Fold
Brand: Eastwest Medico

NIOSH-approved (42 CFR Part 84), FDA-cleared surgical N95 with fluid resistance – vertical-fold design.

NIOSH N95FDA42 CFR Part 84ISO 13485

Sizes

One size fits all

Colour

White

Filtering efficiency

≥ 95 %

NIOSH approval

N95 · 42 CFR Part 84

Sterility

Non-sterile

Shelf life

5 years

Request a quote Download datasheet (PDF)

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

Description

A NIOSH-approved N95 with FDA surgical clearance, for clinical and laboratory work where a fluid-resistant respirator is required. Approval is under 42 CFR Part 84 and filtration exceeds 95 % against non-oil particulates.

The vertical fold holds its shape against the face rather than collapsing inward under breathing load, and it folds flat when not worn. It sits low enough at the bridge to work with goggles or a helmet.

Dual headbands are ultrasonically welded rather than stapled, and a high-density urethane foam nosepiece closes the gap where most leakage happens. Valve-free, individually packed, and passes synthetic blood penetration to ASTM F1862 at 160 mmHg.

Vertical foldDual headbandsAdjustable nose clipUrethane foam nosepieceValve-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

NIOSH

FDA

NIOSH TC-number

Filtering efficiency

≥ 95 %

Synthetic blood penetration (ASTM F1862)

Pass at 160 mmHg

Flammability (16 CFR Part 1610)

Class 1 (≥ 3.5 seconds)

Biocompatibility (ISO 10993)

Pass

Colour

White

Sterility

Non-sterile

Latex status

Not made with natural rubber latex

Shelf life

5 years

Manufacturer QMS

ISO 13485, ISO 9001

NIOSH performance tests

Filter penetration: – N95 particulate filter, 95 % filter efficiency level

Breathing resistance: – meets NIOSH requirements

Exhalation valve leakage: – not applicable (valve-free)

Effective against: particulate aerosols free of oil; time-use restrictions may apply.

Packaging20 pcs/box · 30 boxes/carton

Carton L

Box L

Total

44.0

41.0

42.0

14.0

13.0

10.0

600 pcs

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 (TC ).

Regulatory clearance

FDA-cleared as a surgical N95 respirator with fluid resistance.

Barrier testing

Synthetic blood penetration pass at 160 mmHg (ASTM F1862); flammability Class 1 (16 CFR Part 1610).

Biocompatibility

ISO 10993 – pass.

Manufacturer QMS

ISO 13485, ISO 9001.

NIOSH N95FDA42 CFR Part 84ISO 13485

Ordering

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

Item

Product number

Pack

N95 disposable respirator, vertical fold

EW-N95-VF-01

600 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

Declaration of conformity

PDF

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.