Disposable N95 Medical Mask
Factory-direct disposable N95 medical mask — ≥95% particulate filtration, FDA 510(k) registered, CE (EU MDR) certified, in-house meltblown production.
Built for buyers who need consistent filtration performance across every batch — not just the first one. Our meltblown fabric is produced in-house, so the filtration spec is controlled at the source, not purchased from a third-party roll.
What Makes This a Sourcing Decision, Not Just a Product Selection
The disposable N95 medical mask market has a filtration consistency problem that most buyers discover after the first container arrives. The meltblown nonwoven layer — the component that determines whether a mask actually hits ≥95% PFE — is the one variable that most factories don't control. They buy it from outside suppliers, and when that supplier's batch quality shifts, your masks fail testing. You find out at customs, or worse, after distribution.
We produce our own meltblown fabric. That's the core of what makes our disposable N95 medical mask a different sourcing proposition. We set the fiber diameter, the basis weight, and the electrostatic charge level in-house, batch by batch. When you order 500,000 pieces across three shipments, the filtration performance on shipment three matches shipment one because the material came from the same controlled process — not from whoever had stock available that month.
This product is a cup-shaped or flat-fold N95 respirator designed for single-use clinical and industrial respiratory protection. It meets the ≥95% non-oil-based particulate filtration threshold that defines the N95 classification, and it carries the regulatory clearances — FDA 510(k) and CE under EU MDR — that your downstream buyers, hospital procurement teams, and import compliance officers will ask for before they accept a shipment. The certifications are current and maintained through active surveillance audits, not legacy paperwork.
In-House Meltblown Production
Fiber diameter, basis weight, and electrostatic charge controlled at the source. No third-party roll variability between shipments.
Active Regulatory Clearances
FDA 510(k) and CE (EU MDR) maintained through active surveillance audits — not legacy paperwork from a prior registration cycle.
Multi-Shipment Consistency
500,000 pieces across three shipments — filtration performance on shipment three matches shipment one because the material source is the same controlled process.
Technical Specifications
These are industry-standard parameters for this product type. Actual specifications may vary by configuration — contact us for the exact product data sheet for your order.
Filtration & Performance
Construction & Materials
Physical Dimensions
Certifications & Logistics
Need the exact product data sheet for your configuration?
We'll send the full spec sheet with test reports matched to your target market's regulatory requirements.
In-House Meltblown Production: What It Means for Your Filtration Consistency
This is the section most buyers skip on a product page, and it's the one that matters most for N95 sourcing. Let me explain the mechanism.
Meltblown nonwoven fabric is produced by extruding polymer resin through fine nozzles at high velocity, creating a web of ultra-fine fibers — typically 1–5 μm in diameter — that are then electrostatically charged to enhance particle capture. The filtration efficiency of the finished mask is almost entirely determined by the quality of this layer: fiber diameter consistency, basis weight uniformity, and the strength and distribution of the electrostatic charge. If any of these variables drift between production batches, your BFE and PFE numbers drift with them.
Most mask factories purchase meltblown fabric from nonwoven suppliers. That means their filtration performance is only as consistent as their supplier's process control — and they have no visibility into it. We've seen what happens when that supply chain breaks down: during the 2020–2021 period, factories without their own meltblown capacity were either unable to ship or were shipping masks with filtration performance well below the labeled spec. The buyers holding those contracts were the ones explaining the situation to their customers.
We brought meltblown production in-house specifically to eliminate that dependency. Our meltblown line runs on the same production floor as our mask assembly lines. We set the extrusion parameters, we control the electrostatic treatment, and we batch-test every roll before it enters the mask production line. We test the fabric itself — basis weight, fiber morphology, and electrostatic charge retention — before it ever becomes a mask layer. When our QC lab runs PFE testing on finished masks, we're confirming what we already know about the material, not discovering it for the first time.
For your sourcing operation, this translates directly: the filtration spec you validate on your first sample order is the spec you'll receive on your 20th reorder. That consistency is what protects your downstream relationships — whether you're supplying hospital procurement, fulfilling a government tender, or building a private-label brand that your customers will reorder by name.
Talk to Us About Your Filtration Spec Requirements
Meltblown Layer Control Parameters
-
Fiber Diameter
1–5 μm, controlled at extrusion
-
Basis Weight Uniformity
Batch-tested per roll before assembly
-
Electrostatic Charge
Applied and verified in-house for retention
-
Fiber Morphology
Inspected before mask layer integration
- Outsourced meltblown
- No process visibility
- Batch variance risk
- In-house meltblown
- Full parameter control
- Roll-level QC testing
Regulatory Clearances That Travel With Your Shipment
The certifications on this product are not background information — they are the documents your import compliance team, your hospital procurement contact, and your customs broker will ask for before your shipment clears.
FDA 510(k) Registration
US Market EntryOur 510(k) clearance means this product has been reviewed against the predicate device standard and cleared for commercial distribution in the United States. For buyers supplying US healthcare facilities, government stockpiles, or retail pharmacy chains, this is the non-negotiable entry requirement.
We maintain the registration actively — not as a one-time filing — and the clearance documentation travels with every US-bound shipment.
CE (EU MDR)
European Market AccessCovers European market access under the Medical Device Regulation that replaced the older MDD framework in 2021. The MDR requirements are significantly more demanding than the previous standard — technical documentation, clinical evaluation, post-market surveillance, and a notified body review process.
We completed the MDR transition and hold current CE certification. If you're importing into the EU for the first time, the MDR documentation requirements have caught a lot of buyers off guard. We've been through this with multiple European customers and can walk you through what your importer of record will need before you place the order.
ISO 13485:2016
Medical Device QMSThe quality management system standard specific to medical devices. It's not the same as ISO 9001 — it requires documented risk management, design controls, and traceability at a level that forces a complete rebuild of QC infrastructure.
We completed that work between 2015 and 2017 and have maintained the certification through multiple surveillance audit cycles. The practical effect for your order: every production batch is traceable from raw material lot to finished product, and the documentation survives a compliance audit.
SGS Verification
Third-Party AuditProvides third-party audit confirmation of our testing results and manufacturing claims — an independent check that our in-house test data is accurate. SGS verification gives your procurement team a reference point that doesn't depend on our own reporting.
Market-Specific Compliance Documentation
For buyers supplying the Middle East, Southeast Asia, or Africa, we prepare market-specific compliance documentation on request. The regulatory landscape varies by country, and our export team has handled the documentation requirements for all of our active export markets.
Learn more about our manufacturing capabilities and certificationsProduction Process: Where Consistency Gets Built In
Class 100,000 (ISO 8) Cleanroom
The Class 100,000 (ISO 8) cleanroom is the starting point. Particle counts are monitored continuously, and access is controlled — this is the environment required for medical device manufacturing, and it's what separates a product that passes hospital procurement review from one that doesn't.
Our 6 fully automated production lines run ultrasonic welding for nose wire embedding, ear-loop attachment, and edge sealing.
Ultrasonic Welding: Machine-Controlled Bond Consistency
Ultrasonic welding is worth explaining in terms of what it means for your order quality. The bond strength in an ultrasonically welded joint is determined by machine parameters — frequency, amplitude, pressure, and weld time — not by operator technique. That means the 50,000th mask in your order has the same structural integrity as the first.
We don't have weld quality variation across a shift or across operators. The machine either runs within spec or it stops.
In-line verification: We run weld integrity checks at defined intervals on each line — pull-force testing on ear-loop attachments and peel testing on edge seals. Any line producing out-of-spec welds stops immediately. The cause is identified and corrected before production resumes.
Weld Parameters That Eliminate Operator Variability
Frequency
Machine-set ultrasonic frequency ensures consistent molecular bonding at every weld point.
Amplitude
Controlled vibration amplitude delivers uniform energy transfer to the weld interface.
Pressure
Pneumatic pressure holds materials in precise alignment throughout the weld cycle.
Weld Time
Millisecond-precise dwell time prevents under-bonding or material degradation.
Three-Stage Quality Control Process
The QC process runs in three stages, creating a documented chain of verification from raw material receipt through final shipment.
Incoming Inspection
Covers every raw material lot before anything enters production:
- Spunbond fabric
- In-house meltblown output
- Nose wire
- Ear loops
- Packaging materials
In-Process Inspection
Runs at defined intervals on each line, checking:
- Weld integrity
- Nose wire placement
- Ear-loop attachment force
- Mask dimensions
Outgoing Inspection
The final gate — statistically sampled batch from each production run:
- Full BFE, PFE, and Delta-P testing
- Visual inspection
- Packaging verification
The test reports from outgoing inspection are the documents that travel with your shipment.
Market Segments Where This Product Generates Repeatable Volume
Healthcare Supply Distributors
Supplying hospital systems, clinic networks, and long-term care facilities — this represents the highest-volume segment for this product. Hospital procurement cycles run on annual or multi-year contracts, and once a product is approved and on the formulary, reorders are predictable.
The FDA 510(k) and ISO 13485 documentation we provide is exactly what hospital compliance teams require for vendor qualification — you arrive at the procurement conversation with the paperwork already done.
500,000 to several million pieces per year for mid-size distributors.
Government and Institutional Tender Fulfillment
A segment that rewards suppliers who can produce compliant documentation quickly. Government health agencies, emergency management stockpiles, and military medical supply programs issue tenders with specific certification requirements — FDA clearance for US federal contracts, CE MDR for EU member state procurement, and equivalent national standards for other markets.
Our documentation package is designed to support tender submissions directly: certificate of conformity, test reports, and regulatory clearance documents in the format procurement offices expect.
We've supported buyers through tender submissions in North America, Europe, and the Gulf — if you're preparing a bid, we can tell you exactly what documentation you'll need.
Private-Label Healthcare Brands
Building N95 product lines for pharmacy retail, e-commerce, or institutional sales — our OEM capability lets you go to market under your own brand without building manufacturing infrastructure. The product quality and certifications are already in place — you're adding your brand identity to a validated, certified product.
Minimum runs for OEM packaging start at 50,000 pieces, and we handle artwork integration, packaging format, and label compliance for your target market. This segment has grown significantly for us over the past three years, particularly among buyers building direct-to-institution sales programs.
Industrial Safety Distributors
Supplying construction, manufacturing, and hazardous environment workplaces — N95 respirators are sourced in high volume on recurring purchase cycles. The N95 classification covers non-oil-based particulate hazards — construction dust, metal fumes, certain chemical aerosols — making this product relevant across a wide range of industrial applications.
Industrial buyers typically order in pallet quantities on 30–90 day replenishment cycles, making this a high-frequency, predictable revenue stream for distributors who establish the supplier relationship.
Pallet quantities on 30–90 day cycles — high-frequency, predictable volume.
OEM and Private-Label Configuration Options
Standard OEM work — your brand on our existing product — is straightforward. You provide artwork files and packaging specifications, we run a sample approval, and full production follows. The product itself doesn't change; the packaging carries your brand identity.
For buyers who need product-level customization, our engineering team handles modifications directly:
Headband vs. Ear-Loop
Standard headband (two-strap) for clinical use; ear-loop variant available for markets where headband compliance isn't required.
Valved vs. Non-Valved
Exhalation valve reduces breathing resistance for extended wear; non-valved is required for surgical environments and some institutional procurement specs.
Flat-Fold vs. Cup Shape
Flat-fold packs more efficiently (lower shipping cost per unit); cup shape provides a more consistent facial seal profile for users with varying face geometries.
Color
White is standard; custom colors available on OEM runs — ask about minimum quantities for color changes.
Packaging Format
Individual poly bag (standard), retail box (pharmacy/e-commerce), bulk clinical pack, or custom retail-ready packaging for shelf display.
Private-Label Printing
Full-color carton and inner box printing, including regulatory text, barcode, and market-specific labeling requirements.
Minimum Order Quantities
MOQ for standard SKUs is 50,000 pieces. Custom configurations — modified product specs, non-standard packaging formats, or new SKU development — typically require higher minimums to justify line setup and material procurement.
We'll tell you the actual number upfront, not after you've approved samples.
Container Loading and Landed Cost Planning
Standard carton configuration: 20 pieces per inner box, 25 inner boxes per master carton (500 pieces per carton). Master carton dimensions are designed for container loading efficiency — we've optimized the carton footprint to minimize wasted cubic space in both 20GP and 40HQ containers.
Approximate Container Loading Capacity
Depending on configuration
Depending on configuration
These figures are for planning purposes — actual loading depends on your specific packaging configuration. We provide exact CBM per carton and container loading calculations with every quotation so your freight forwarder has accurate numbers before booking.
Landed Cost Insight: Flat-Fold vs. Cup Shape
For buyers calculating landed cost: the flat-fold configuration packs approximately 15–20% more efficiently than the cup-shape configuration at equivalent piece count, which translates directly to lower freight cost per unit.
If your downstream market accepts either configuration, this is worth factoring into your sourcing decision.
Market note: Most of our North American buyers land on flat-fold for this reason — the cup shape commands a slight premium in some clinical segments, but the freight savings on flat-fold are real.
Frequently Asked Questions
Detailed answers to the procurement and technical questions we hear most from distributors, hospital supply chain teams, and government health agencies.
What is the difference between NIOSH-approved N95 and FDA 510(k) registered N95?
NIOSH approval (from the US National Institute for Occupational Safety and Health) certifies that a respirator meets the filtration and fit requirements for occupational use — construction, industrial, and general workplace respiratory protection. FDA 510(k) clearance certifies that the device meets medical device standards for use in healthcare settings, including surgical environments.
A mask can hold one, both, or neither. For healthcare procurement — hospital supply chains, clinical settings, government health stockpiles — FDA 510(k) is the relevant clearance. For industrial distribution, NIOSH approval is the standard buyers look for.
Our disposable N95 medical mask carries FDA 510(k) registration and CE (EU MDR) certification, making it qualified for healthcare procurement in the US and EU markets. If your target market requires NIOSH approval specifically, contact us to discuss the applicable configuration.
What filtration performance can I expect across multiple production batches?
Because we produce our own meltblown nonwoven fabric in-house, filtration performance is controlled at the material level, not just at the finished-product testing stage. We batch-test every roll of meltblown fabric before it enters production — basis weight, fiber morphology, and electrostatic charge retention.
Finished masks from every production run go through BFE and PFE testing in our in-house QC lab before outgoing inspection.
We can provide historical test data from previous production runs on request.
What documentation do you provide for import compliance?
Standard documentation with every shipment: certificate of conformity, BFE/PFE/Delta-P test reports (in-house and third-party), FDA 510(k) clearance documentation, CE technical file summary, ISO 13485 certificate, packing list, and commercial invoice.
For market-specific requirements — FDA import records, EU MDR importer declarations, Gulf SFDA equivalents — our export team prepares the additional documentation your customs broker or compliance officer needs.
We've handled import documentation for all of our active export markets and can tell you exactly what your shipment will need before you place the order.
What is the MOQ, and can I order a sample before committing to a full production run?
MOQ for standard SKUs is 50,000 pieces. For new buyers evaluating the product, we support sample orders before full production commitment — sample quantities and lead times vary by configuration.
Most buyers in this category start with a sample evaluation to test filtration performance with their own equipment or submit to their own third-party lab before placing the first production order.
Contact us with your target configuration and we'll confirm sample availability and lead time.
How does the valved vs. non-valved configuration affect market suitability?
The exhalation valve reduces breathing resistance and heat buildup during extended wear, which improves user compliance in industrial and long-duration use settings.
However, valved N95s are not appropriate for surgical environments — the valve allows unfiltered exhaled air to pass through, which creates a source control problem in sterile fields. Many hospital procurement specs and some government tender requirements explicitly require non-valved N95s.
If you're supplying healthcare facilities or responding to institutional tenders, confirm the valve requirement before specifying your order.
We produce both configurations; the non-valved version is our standard for healthcare-channel buyers.
What are the CE MDR documentation requirements for EU import?
Under EU MDR (Regulation 2017/745), importing a medical device into the EU requires an EU-authorized representative, a notified body certificate (for Class I medical devices with a measuring function or sterile devices, and Class IIa and above), and a complete technical file. N95-equivalent respirators classified as medical devices fall under this framework.
We hold current CE certification under EU MDR and can provide the technical documentation your EU importer of record needs.
The MDR requirements changed significantly from the previous MDD framework — if you're new to EU import for this product category, we recommend discussing the documentation requirements with us before your first order.
Sibling Product: Hospital N95 Medical Mask
If your buyers are specifically hospital procurement teams or surgical suite supply chains, our Hospital N95 Medical Mask is configured for that segment — with documentation and packaging optimized for institutional healthcare procurement, including surgical-environment compliance (non-valved, sterile packaging options, and hospital formulary documentation support).
The disposable N95 medical mask on this page is the broader-market configuration — suited for healthcare distribution, industrial safety, government stockpile, and private-label programs where the buyer needs a certified N95 with flexible packaging and OEM capability. If your channel is specifically acute-care hospital supply, the hospital N95 configuration may be a better fit.
Key Differences at a Glance
Get a Quote for This Disposable N95 Medical Mask
Send us your target configuration — headband or ear-loop, valved or non-valved, flat-fold or cup shape — along with your volume and target market. We'll come back with a detailed quote, container loading calculations, and the specific compliance documentation your market requires.
If you're evaluating us against other suppliers, ask for our historical batch test data. We'll send BFE and PFE results from recent production runs so you can compare filtration consistency, not just the spec sheet claim.