N95 Medical Masks Manufactured by eztio
Certified N95 medical masks from a dedicated manufacturer with in-house meltblown filtration production and FDA 510(k) registration.
Two product configurations — disposable N95 and hospital-grade N95 — built in a Class 100,000 cleanroom and tested in-house for BFE, PFE, and Delta-P before every shipment.
What Makes an N95 Different — and Why the Source of the Filtration Layer Matters
An N95 respirator is defined by one number: ≥95% filtration efficiency against non-oil-based particulates at 0.3 microns. That spec is set by NIOSH, and it's not negotiable. What is variable — and what most buyers don't think to ask about — is where the meltblown nonwoven fabric that achieves that filtration comes from.
Most mask factories buy meltblown from outside suppliers. That means their filtration performance is only as consistent as their supplier's last production run. We produce our own meltblown fabric in-house. We set the fiber diameter, the basis weight, and the electrostatic charge level ourselves, batch by batch. When you order N95 medical masks from us, the ≥95% BFE figure isn't a claim we're making based on a supplier's spec sheet — it's a result we're producing and testing in our own lab before the masks leave the building.
This distinction matters most when supply chains tighten. Factories without in-house meltblown either stop shipping or quietly substitute lower-grade fabric. We've watched both happen. Our buyers didn't notice because their orders kept arriving on spec.
Key N95 Parameters We Control
- Fiber diameter of meltblown layer
- Basis weight (g/m²) per batch
- Electrostatic charge level
- BFE, PFE, and Delta-P tested in-house
N95 Product Line
We manufacture two N95 configurations, each targeting a distinct channel and compliance requirement. Both are produced on the same automated lines, in the same cleanroom, with the same in-house meltblown filtration layer.
Disposable N95 Medical Mask
The standard cup-style or flat-fold N95 for general healthcare, industrial hygiene, and institutional distribution. Filtration efficiency ≥95% against non-oil-based particulates, with a Delta-P (breathability) value that keeps the mask wearable across a full shift. Available in ear-loop and head-strap configurations.
This is the SKU most of our wholesale and distribution buyers run — it moves in volume, it clears customs cleanly with our FDA and CE documentation, and the 50,000-piece MOQ makes it accessible for market-entry programs.
Hospital N95 Medical Mask
The surgical N95 configuration — cleared for use in environments where both airborne particulate protection and fluid resistance are required. This product meets the combined requirements of NIOSH N95 and ASTM F2100 Level 2 or equivalent, making it the specification that hospital procurement teams and government tender documents typically call for.
If your buyers are stocking ICUs, operating theaters, or emergency departments, this is the configuration they need — and the one that requires the most complete documentation package at import.
Technical Specifications Across the N95 Range
These are category-level ranges covering both N95 configurations. Exact values for each product are on the individual product pages.
| Parameter | Specification |
|---|---|
| Filtration efficiency (particulate) | ≥95% PFE (non-oil-based, 0.3 μm) |
| Bacterial filtration efficiency (BFE) | ≥95% |
| Breathability (Delta-P) | ≤35 mmH₂O/cm² (standard); ≤25 mmH₂O/cm² (hospital grade) |
| Fluid resistance (hospital N95) | ≥120 mmHg synthetic blood penetration resistance |
| Nose wire | Aluminum, 0.5–0.8 mm, fully embedded via ultrasonic welding |
| Ear loop / head strap | Elastic nonwoven or flat elastic; tensile strength ≥10 N per loop |
| Outer / inner layer | Spunbond polypropylene nonwoven, 25–30 gsm |
| Filtration layer | In-house meltblown polypropylene, electrostatically charged |
| Cleanroom environment | Class 100,000 (ISO 8) |
| Certifications | FDA 510(k), CE (EU MDR), ISO 13485:2016, ISO 9001:2015, SGS |
| Available configurations | Cup-style, flat-fold; ear-loop, head-strap |
| Standard carton | 20 pcs/box, 25 boxes/carton (500 pcs/carton) — adjustable for OEM |
| MOQ (standard SKUs) | 50,000 pieces |
We test every production batch in-house for BFE, PFE, and Delta-P before outgoing inspection. Third-party test reports are available with each shipment for import documentation.
In-House Meltblown Production: The Filtration Layer We Control
This is the capability that shapes everything else about our N95 output, so it deserves a direct explanation.
Meltblown nonwoven fabric is the middle layer of an N95 — the one that does the actual filtration work. It's produced by extruding polypropylene through fine nozzles at high velocity, creating a web of fibers with diameters in the 1–5 micron range. The electrostatic charge applied during production is what gives the fabric its ability to capture sub-micron particles at ≥95% efficiency. Get the fiber diameter wrong, the basis weight wrong, or the charge level wrong, and the mask fails its filtration test. There's no way to fix it after the fact.
We run our own meltblown extrusion line. Our engineers set the process parameters — melt temperature, air pressure, collector distance, charging voltage — for each production run, and we batch-test the output before it goes to the mask production lines. If a roll of meltblown doesn't hit our internal BFE threshold, it doesn't go into masks. It gets pulled, the process parameters get reviewed, and we run again.
For your order, this means the filtration spec you're buying is controlled at the source, not dependent on a third-party supplier's consistency. It also means we can adjust filtration targets for custom configurations — if you need a mask that exceeds the standard ≥95% threshold for a specific tender requirement, we have the process levers to do that. (We've done this for several government procurement programs where the spec called for ≥98% BFE. It requires a tighter meltblown process and a higher rejection rate on the fabric side, but it's achievable because we control the production.)
Process Parameters We Control
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Melt temperature
-
Air pressure
-
Collector distance
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Charging voltage
Batch-to-Batch Consistency for Your Reorders
The practical commercial implication: your reorders match your initial orders. The meltblown spec doesn't drift between batches because a supplier changed their process. Your downstream customers — whether they're hospital procurement teams or retail buyers — get consistent product across every shipment.
Regulatory Clearance for the Markets You Sell Into
N95 medical masks sit at the intersection of two regulatory frameworks: NIOSH (US) and EU MDR (Europe), with additional requirements for Gulf states, Southeast Asia, and other markets. Our certification stack covers the primary import markets.
FDA 510(k) Registered
US market clearance for medical devices. This is the document your US customs broker and hospital procurement contacts will ask for. We maintain active registration and can provide the 510(k) number and supporting technical documentation with your order.
CE (EU MDR)
European Conformity marking under the Medical Device Regulation. Since the EU MDR replaced the older MDD framework in 2021, the documentation requirements for importers have become significantly more demanding. We've been through the MDR transition with multiple European buyers and have the full technical file in place.
ISO 13485:2016
Medical device quality management system. This is the process certification that underpins the product certifications. It covers design controls, risk management, traceability, and corrective action — the infrastructure that makes the product certifications credible.
SGS Verified
Third-party audit and testing verification, available for buyers whose procurement process requires independent lab confirmation beyond the manufacturer's own test reports.
Importing into the EU for the first time under MDR?
Talk to us before you place the order. The importer of record obligations have caught several buyers off guard, and we can walk you through what your compliance team will need. The documentation requirements under MDR are significantly more demanding than the older MDD framework.
Markets Outside North America and Europe
For Gulf states, Southeast Asia, Africa — documentation requirements vary. Our export team has handled shipments to all of our active markets and can prepare the specific declaration formats and test report packages your customs process requires.
Contact us with your destination market and we'll confirm what documentation travels with your order
Where N95 Medical Masks Move: Market Segments Worth Sourcing For
N95 respirators serve a narrower set of channels than standard surgical masks, and the buying patterns in each channel are distinct. Understanding where the volume is helps you build the right sourcing position.
Hospital & Clinical Procurement
Highest-specification channelHospital systems — particularly in North America and Europe — require the surgical N95 configuration with fluid resistance, full regulatory documentation, and often a vendor qualification process before the first order. The order volumes are large and repeatable, but the entry requirements are real.
Our fit: Hospital N95 configuration — FDA 510(k) cleared, CE marked, with test reports that survive procurement audit.
Government & Institutional Tenders
Health ministries, emergency agencies, military medicalHealth ministries, emergency management agencies, and military medical commands typically issue tenders with explicit specification requirements: NIOSH N95, specific BFE/PFE thresholds, sometimes country-of-origin requirements. We've supplied into this channel across multiple markets.
Our fit: Documentation package designed to support tender submission, not just import clearance.
Wholesale Distribution & Healthcare Supply Chains
Volume channel for disposable N95Distributors stocking regional healthcare networks, pharmacy chains, and occupational health suppliers typically run on 6–12 month forward contracts with quarterly delivery schedules. This is where the disposable N95 configuration moves in volume.
Our fit: 50,000-piece MOQ on standard SKUs — large enough to be efficient, small enough to work for distributors building their N95 position rather than already running full container loads.
Private-Label Healthcare Brands
OEM capability for branded PPE linesCompanies building their own branded PPE lines for retail, e-commerce, or institutional sales use our OEM capability to put their brand on a certified N95 product without building their own manufacturing infrastructure. We handle the packaging, the labeling, and the regulatory documentation under their brand.
Our fit: The certification stays with the product; the brand stays with the buyer.
Occupational Health & Industrial Hygiene
The occupational health and industrial hygiene channel — construction, mining, manufacturing — is a volume segment that often gets overlooked by healthcare-focused distributors. NIOSH N95 is the standard specification for respiratory protection in these environments, and the buying cycle is driven by safety compliance programs rather than healthcare procurement.
If you're not already in this channel, it's worth evaluating.
How to Choose Between Disposable N95 and Hospital N95
The decision comes down to two questions: what does your end market require, and what documentation does your import process need?
Choose the Disposable N95
If your buyers are in occupational health, general healthcare settings, wholesale distribution, or retail. This configuration meets NIOSH N95 filtration requirements and carries our FDA and CE documentation, but it is not rated for surgical environments where fluid resistance is required.
Ideal Channels
Choose the Hospital N95
If your buyers are hospital systems, surgical centers, or any institutional buyer whose procurement spec explicitly requires fluid resistance alongside particulate filtration. This configuration meets the combined NIOSH N95 + ASTM F2100 Level 2 (or equivalent EN 14683 Type IIR) requirements.
Ideal Channels
Don't substitute configurations
Don't substitute the disposable configuration into a hospital tender that specifies fluid resistance — it won't pass the procurement audit. The hospital N95 carries a higher unit cost and a slightly longer lead time for first orders due to the additional compliance verification steps, but it's the right product for the right channel.
Building a Product Line for Both Channels?
We can run both SKUs under your brand. Most of our private-label buyers in North America and Europe carry both configurations — the disposable N95 for their distribution business and the hospital N95 for their institutional accounts.
QC Infrastructure: What Happens Before Your Order Ships
The three performance parameters that define an N95 — BFE, PFE, and Delta-P — are tested in our in-house lab on every production batch. This is not a sampling exercise on a subset of orders; it runs on every batch, every time.
Incoming Inspection
Every raw material lot is inspected before it enters production — meltblown fabric, spunbond nonwoven for outer and inner layers, nose wire, ear loops, and packaging materials.
Material that doesn't pass doesn't go to the production floor.
In-Process Inspection
Runs at defined intervals on each production line. When a line produces out-of-spec product, it stops. The cause is identified and corrected before production resumes.
This is the discipline ISO 13485 requires — built into standard operating procedure.
Outgoing Inspection
The final gate. A statistically sampled batch from each production run goes through full performance testing. Test reports travel with your shipment and support your import documentation.
Reports support your import documentation at destination.
Why In-House Lab Capability Matters to Your Business
The in-house lab capability means problems are caught before they become shipment problems. A batch that fails internal BFE testing gets pulled and investigated — it doesn't get shipped and discovered at your customer's receiving dock.
The alternative — running defective product and sorting it out later — creates the kind of batch-level quality variance that shows up as warranty claims on your end. We've built stop-the-line discipline into standard operating procedure because most factories find it operationally uncomfortable, and that discomfort is exactly what protects your downstream quality.
OEM and Private-Label N95 Programs
We handle OEM and ODM projects for N95 masks directly — custom packaging, private-label printing, modified configurations, and new SKU development. The process is straightforward for standard OEM work: artwork files, packaging spec confirmation, and a sample approval run before full production.
For private-label programs, we produce shelf-ready retail packaging or bulk clinical packaging depending on your downstream channel. Carton configuration, inner box design, label content, and language variants are all handled in-house. The regulatory documentation — FDA 510(k) registration, CE technical file, test reports — is maintained under our manufacturer registration and travels with your branded product.
MOQ for standard OEM SKUs starts at 50,000 pieces. Custom configurations — modified ear-loop geometry, different headband materials, non-standard packaging formats — typically require a higher minimum to justify line setup and material procurement. We'll tell you the minimum upfront, before you've invested in sample approval.
ODM projects, where you need a modified filtration spec or a configuration we don't currently run, go through our product development process. Because we control our own meltblown production, we can adjust filtration parameters for custom targets. If your tender requires ≥98% BFE rather than the standard ≥95%, that's a process adjustment we can make — it's not a new product development project from scratch.
Tell Us Your Brand RequirementsStandard OEM Process
- 1 Artwork files & packaging spec submission
- 2 Packaging spec confirmation & sample approval run
- 3 Full production & QC inspection
- 4 Shipment with regulatory documentation under your brand
Private-Label Scope
- Shelf-ready retail packaging or bulk clinical packaging
- Carton configuration & inner box design
- Label content & language variants
- FDA 510(k), CE technical file, test reports travel with your brand
ODM Capability
Need ≥98% BFE instead of standard ≥95%? Because we control our own meltblown production, custom filtration targets are a process adjustment — not a ground-up development project.
Packaging, Container Loading, and Landed Cost
N95 masks are a volume-sensitive product — the difference between efficient and inefficient carton configuration can shift your landed cost per unit by 8–12% on a full container load. We've optimized our standard carton sizes for 20GP and 40HQ loading.
Container Loading Optimization
Master carton dimensions are designed to stack without wasted cubic space in standard container configurations. For a 40HQ container, this translates to approximately 1.2–1.5 million pieces depending on the specific N95 configuration (cup-style vs. flat-fold have different carton profiles).
For OEM programs, carton configuration can be adjusted to match your retail or clinical packaging requirements. If your downstream channel requires individual retail boxes rather than bulk clinical packaging, we can produce that format — the per-unit cost increases slightly due to packaging material, but the shelf-ready format eliminates your downstream repacking cost.
Export Documentation
Export documentation travels with every shipment: certificate of conformity, BFE/PFE/Delta-P test reports, packing list, and any market-specific declarations your customs broker requires.
Market-Specific Documentation
- US imports: FDA registration documentation provided
- EU imports: CE technical file summary and Declaration of Conformity
- Gulf state imports: SFDA-equivalent documentation prepared on request
Lead Time
15–25 days from order confirmation on standard SKUs. We give you a specific ship date, not a range, once we confirm your order volume and current line scheduling.
Landed Cost Impact
Efficient vs. inefficient carton configuration shifts your landed cost per unit by 8–12% on a full container load. Our standard carton sizes are optimized for 20GP and 40HQ loading to keep your per-unit cost as low as possible.
Frequently Asked Questions
What is the MOQ for N95 medical masks, and can I order both configurations in one shipment?
MOQ for standard N95 SKUs is 50,000 pieces per configuration. Yes, you can combine the disposable N95 and hospital N95 in a single shipment — each configuration meets its own MOQ independently. Combined orders are common for buyers who serve both distribution and institutional channels under the same brand.
What is the difference between NIOSH N95 and the surgical N95 (hospital N95)?
NIOSH N95 certification covers particulate filtration efficiency — ≥95% against non-oil-based particles at 0.3 microns. A surgical N95 adds fluid resistance to that requirement, typically ≥120 mmHg synthetic blood penetration resistance per ASTM F1862. Hospital procurement specs almost always require the surgical N95 because clinical environments involve both airborne and fluid exposure risks. If your tender or procurement spec doesn't explicitly require fluid resistance, the standard disposable N95 is sufficient and lower cost.
How do you ensure BFE and PFE consistency across reorders?
We produce our own meltblown nonwoven fabric in-house, which means the filtration layer spec is controlled at the source rather than dependent on a third-party supplier. Every production batch of meltblown is tested against our internal BFE threshold before it goes to the mask production lines. Every batch of finished masks is tested for BFE, PFE, and Delta-P in our in-house lab before outgoing inspection. Reorder consistency is a direct result of controlling the filtration material ourselves — the process parameters don't change between your first order and your tenth.
What documentation do you provide for US and EU import?
For US imports:
FDA 510(k) registration documentation, certificate of conformity, and BFE/PFE/Delta-P test reports.
For EU imports:
CE Declaration of Conformity, CE technical file summary, and test reports per EN 149 or equivalent.
Both documentation packages are prepared with every shipment. If your customs broker or compliance team needs additional declarations or market-specific formats, contact us before the order ships — we've handled documentation for all of our active export markets and can prepare what you need.
Can you produce N95 masks with a filtration spec above the standard ≥95% threshold?
Yes. Because we control our own meltblown production, we can adjust process parameters to target higher filtration efficiency — ≥98% BFE is achievable. This requires a tighter meltblown process and a higher internal rejection rate on the fabric side, which affects unit cost and lead time. We've done this for government procurement programs with elevated spec requirements. If your tender calls for above-standard filtration, send us the spec document and we'll confirm feasibility and pricing.
What is the lead time for a first order versus a reorder?
First orders on standard SKUs: 15–25 days from order confirmation, depending on volume and current line scheduling.
Reorders on established SKUs with approved samples: typically 10–20 days.
Custom OEM configurations with new packaging: additional 5–10 days for sample production and approval before the production run starts.
We give you a specific ship date at order confirmation — not a range.
Source N95 Medical Masks from eztio
We've been manufacturing certified medical masks since 2012. Our N95 line is built on in-house meltblown production, Class 100,000 cleanroom manufacturing, and a QC process that tests every batch before it ships.
FDA 510(k) registered and CE (EU MDR) marked — the documentation your buyers need is already in place.
Two configurations. Two channels. One factory that controls the filtration layer.
eztio — Gaomi Eztio Medical Technology Co., Ltd.
Building 3, Zhilan Industrial Park, No. 88 Heng'er Road, Gaomi Economic Development Zone, Gaomi, Weifang, Shandong, 261500, China
+86 190 0636 0409
WhatsApp: +86 190 0636 0409
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