Surgical Medical Masks Manufacturer & Wholesale Supplier
Certified surgical medical masks from a dedicated manufacturer — ISO 13485, CE (EU MDR), and FDA 510(k) registered.
Three product lines covering disposable surgical, N95 respirator, and 3-ply configurations — all produced in a Class 100,000 cleanroom with in-house meltblown filtration fabric.
What We Make and How We're Set Up to Supply You
We've been manufacturing surgical medical masks since 2012 — one product category, one facility, built around it. Our factory, Gaomi Eztio Medical Technology Co., Ltd., sits in the Zhilan Industrial Park in Gaomi, Shandong, covering 12,000 square meters. Six fully automated production lines run inside a Class 100,000 (ISO 8) cleanroom. Annual output is 120 million pieces.
The certifications we hold — ISO 13485:2016, CE under EU MDR, FDA 510(k) registration, ISO 9001:2015, and SGS — cover the regulatory requirements for the markets most of our buyers sell into. If you're importing into the US, the EU, or the Gulf states, the compliance documentation travels with your shipment.
One thing that separates our operation from most surgical mask factories: we produce our own meltblown nonwoven fabric. That's the middle filtration layer — the component that determines whether a mask actually hits its BFE or PFE spec. Most factories buy it from outside suppliers and have no control over batch-to-batch consistency. We extrude it ourselves, which means we set the fiber diameter, basis weight, and electrostatic charge to match the filtration target we're building toward. When you order a mask rated at ≥95% BFE, we know what's in it because we made the material.
For a deeper look at our facility and quality system, see About eztio.
Certifications Held
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ISO 13485:2016Medical device QMS
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CE (EU MDR)European market access
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FDA 510(k)US market registration
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ISO 9001:2015Quality management
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SGS VerifiedThird-party audit
Facility Snapshot
- Location
- Gaomi, Shandong
- Floor Area
- 12,000 m²
- Cleanroom Class
- ISO 8 (100K)
- Production Lines
- 6 Automated
- Annual Capacity
- 120M pieces
- In-House Meltblown
- Yes
Export Markets
North America, Europe, Middle East, Southeast Asia, Africa
In-House Meltblown: Why It Matters for Your Order
The meltblown nonwoven layer is the filtration core of every surgical mask. We extrude it ourselves — setting fiber diameter, basis weight, and electrostatic charge to match the exact BFE or PFE target for your order. This eliminates the batch-to-batch variability that comes from sourcing meltblown on the open market. When you order a mask rated at ≥95% BFE, we control the material that delivers that number.
Surgical Mask Product Line
We produce three surgical medical mask variants under this category. Each is designed for a distinct performance tier and market application — the differences matter when you're matching product to channel.
Disposable Surgical Medical Mask
The standard 3-ply flat-fold configuration: spunbond outer layer, meltblown filtration core, soft inner layer. This is the highest-volume SKU in our lineup — the product that fills hospital procurement contracts, pharmacy distribution programs, and institutional supply chains. BFE ≥95%, ear-loop or tie-on configurations available, individually wrapped or bulk-packed depending on your downstream channel. If you're building a repeatable, high-volume supply program, this is the product to start with.
N95 Surgical Medical Mask
Cup-shaped respirator meeting N95 filtration standards (≥95% particulate filtration efficiency at 0.3 microns), with surgical-grade fluid resistance for operating room and high-risk clinical environments. This product sits at the intersection of respiratory protection and surgical barrier requirements — the configuration that hospital procurement teams specify when they need both. FDA 510(k) clearance and NIOSH-equivalent testing documentation available. This is the SKU that gets scrutinized hardest at customs — we've been through the import documentation process with buyers in multiple markets and can walk you through what your compliance team will need.
3 Ply Medical Mask
Three-layer construction optimized for ASTM F2100 Level 1, Level 2, and Level 3 performance tiers. The distinction between levels matters for your buyers: Level 1 covers general clinical use, Level 2 covers moderate fluid exposure, Level 3 covers high-fluid-exposure surgical procedures. We produce all three tiers from the same production line with different meltblown specifications — your order can be configured to the exact ASTM level your market requires without switching suppliers.
Technical Specifications Across the Surgical Mask Range
These are category-level parameter ranges. Exact values for each product are on the individual product pages.
| Parameter | Range / Standard |
|---|---|
| Filtration layers | 3-ply (standard) |
| Outer / inner layer material | Spunbond polypropylene nonwoven, 25–35 gsm |
| Filtration layer (meltblown) | In-house produced, 20–40 gsm, electrostatic-charged |
| BFE (Bacterial Filtration Efficiency) | ≥95% (standard) / ≥98% (high-spec) |
| PFE (Particulate Filtration Efficiency) | ≥95% at 0.1 μm (N95 configuration) |
| Delta-P (breathability) | ≤5.0 mmH₂O/cm² (ASTM F2100 compliant) |
| Fluid resistance | ≥80 mmHg (Level 1) / ≥120 mmHg (Level 2) / ≥160 mmHg (Level 3) |
| Nose wire | Single or double aluminum wire, 0.45–0.55 mm diameter |
| Ear loop material | Elastic polyurethane, tensile strength ≥10 N |
| Mask dimensions (adult) | 175 × 95 mm (±3 mm tolerance) |
| Sterilization | EO (ethylene oxide) sterilization available on request |
| Shelf life | 2 years from production date |
| Applicable standards | ASTM F2100, EN 14683, YY 0469 |
In-House Batch Testing
We test BFE, PFE, and Delta-P in-house on every production batch before outgoing inspection.
Third-Party Verification
Third-party test reports from SGS and equivalent labs are available with your order documentation.
Applicable Standards
- ASTM F2100
- EN 14683
- YY 0469
Fluid Resistance Levels at a Glance
Low-risk procedures, general examination use
Moderate-risk procedures, light fluid exposure
High-risk procedures, heavy fluid or splash exposure
In-House Meltblown Production: What It Means for Your Filtration Specs
This is the capability that most directly affects your product's performance consistency, so it deserves more than a bullet point.
Meltblown nonwoven fabric is produced by extruding molten polypropylene through fine nozzles under high-velocity hot air, creating a web of microfibers with diameters in the 1–5 micron range. The electrostatic charge applied during production is what gives the layer its filtration efficiency — it attracts and traps particles that would otherwise pass through a purely mechanical barrier.
The problem with buying this material from outside suppliers is that the charge dissipates over time, and different production batches from the same supplier can have meaningfully different charge levels. You don't find out until your BFE test comes back at 91% instead of 95%.
We brought meltblown production in-house in 2017. We run our own extrusion line, control the polymer grade, the die temperature, the air velocity, and the electrostatic treatment parameters. Every roll we produce is batch-tested before it enters mask production.
When we commit to a BFE spec on your order, we're not relying on a supplier's certificate of conformity — we're relying on our own process data.
What We Control In-House
Microfiber Diameter
Fiber diameter range in our meltblown web, creating the mechanical and electrostatic barrier that captures sub-micron particles.
Why This Matters at the Contract Level
For buyers supplying hospital procurement programs or government tenders, spec consistency across a 500,000-piece order is not a given in this industry. For us, it's a process control problem we solved by owning the upstream step.
We've had buyers come to us specifically after a competitor's order failed incoming inspection at their customer's facility — the failure was always the meltblown layer.
Cleanroom Manufacturing and the QC Process Behind Your Certificate
ISO 8 (Class 100,000) Cleanroom
- Continuous particle monitoring throughout production
- Controlled access with full gowning protocol for all staff
- Manufacturing baseline for clinical-environment products
For a product that goes into clinical environments, this is the manufacturing baseline, not a premium feature.
Our core mask production runs in a Class 100,000 (ISO 8) cleanroom — continuous particle monitoring, controlled access, gowning protocol for all production staff. The QC process runs in three stages:
Incoming Inspection
Covers every raw material lot before it enters production: spunbond fabric, meltblown rolls (our own production, still batch-tested), nose wire, ear loops, and packaging materials.
Checked at the dock — nothing enters production without passing incoming QC.
In-Process Inspection
Runs at defined intervals on each line. Any line producing out-of-spec product stops. We don't run defective product to the end of the shift and sort it out later.
This is the part of ISO 13485 that most factories find uncomfortable — stopping a running line costs money. We've built it into the standard operating procedure because the alternative costs more.
Outgoing Inspection
The final gate: statistically sampled batches go through full testing, plus visual inspection, packaging integrity check, and label verification. The test reports from this stage are the documents that travel with your shipment and support your import documentation.
Regulatory Coverage by Market
FDA 510(k) registration and CE under EU MDR are the two certifications that determine whether your shipment clears customs in the US and EU without a compliance hold. We maintain both because most of our buyers operate in one or both of those markets.
Importing into the EU since MDR replaced MDD?
If you're importing into the EU for the first time since MDR replaced MDD in 2021, the technical file requirements have changed significantly. We've been through this with multiple European buyers and can prepare the documentation your importer of record will need.
Market Segments Where Surgical Masks Move at Volume
Surgical medical masks are not a single-channel product. The buyers we supply operate in distinct segments with different procurement cycles, volume profiles, and compliance requirements — understanding which segment you're serving shapes which product configuration and documentation package you need.
Hospital & Clinical Supply Chains
Procurement teams at hospital networks and group purchasing organizations buy on annual or multi-year contracts, typically specifying ASTM Level 2 or Level 3 for surgical use and Level 1 for general clinical use.
The compliance bar is high: FDA 510(k) or CE documentation is non-negotiable, and incoming inspection at the hospital's receiving dock is standard. This is the segment where our in-house meltblown consistency and three-stage QC process directly protect your contract.
Government & Institutional Tenders
National health ministries, military medical procurement, and large institutional buyers (prisons, schools, transit authorities) issue tenders with defined technical specifications and mandatory certification requirements.
Tender cycles are predictable, volumes are large, and the documentation requirements are exhaustive.
Export Experience
We've supplied buyers fulfilling tenders in the Middle East, Southeast Asia, and Africa — the export documentation package we prepare is designed to survive compliance review.
Healthcare Distributor Programs
Distributors building a surgical mask SKU for their catalog need a product that's compliant, consistently spec'd, and available for reorder without surprises.
Large enough to be commercially meaningful, small enough to test a new SKU before committing to a full container.
Private-Label Healthcare Brands
Brands building their own labeled surgical mask line need OEM packaging capability alongside the product itself.
We handle private-label printing, custom packaging formats, and retail-ready configurations in-house. Your brand goes to market without a separate packaging supplier in the chain.
OEM/ODM Packaging and Custom Configuration
Standard OEM Work
Your brand on our existing product — straightforward: artwork files, packaging spec confirmation, sample approval, then full production. We can produce shelf-ready retail packaging, bulk clinical packaging, or individually wrapped configurations depending on your downstream channel.
Custom Configurations
For modified filtration specs, different ear-loop materials, non-standard mask dimensions, or new packaging formats — our engineering team handles development directly. We have the in-house capability to adjust meltblown parameters for different filtration targets and modify production line settings for non-standard configurations.
Minimum Order Quantities
Standard SKUs: 50,000 pieces. Custom configurations: typically require a higher minimum to justify line setup and material procurement — we'll tell you that upfront, before you've approved samples.
OEM Process Flow
Available Packaging Formats
- Shelf-ready retail packaging
- Bulk clinical packaging
- Individually wrapped configurations
- Private-label printing (in-house)
- Custom box dimensions & formats
What Goes Wrong with Surgical Mask Orders — and How We Prevent It
This industry has well-documented failure modes. Buyers who've been sourcing surgical masks for more than one cycle have usually encountered at least one of them.
BFE Spec Failure on Incoming Inspection
The most common problem — almost always a meltblown issue
The Problem
The supplier's test report shows ≥95% BFE; your customer's incoming inspection shows 88%. The gap is usually explained by meltblown fabric from a batch with degraded electrostatic charge, or a supplier who substituted a lower-spec fabric without disclosure.
Our Prevention
In-house meltblown production with batch-level testing before the fabric enters the production line. We don't buy filtration performance from a supplier — we produce it.
Ear-Loop Failure Under Clinical Use
Passes static pull test, fails after 4 hours of continuous wear
The Problem
Ear loops that pass a static pull test but fail after 4 hours of continuous wear are a real problem in clinical settings — and a warranty claim problem for the distributor who supplied them. The failure mode is usually a combination of low-grade elastic material and inadequate ultrasonic weld strength at the attachment point.
Our Prevention
We specify polyurethane elastic with a minimum tensile strength of 10 N and run attachment force testing at defined intervals on each production line. We switched to a higher-spec elastic supplier in 2020 after seeing field reports from a European buyer — the cost difference per mask is under $0.001, but the warranty claim exposure it eliminates is significant.
Batch-to-Batch Dimensional Inconsistency
Causes downstream operational problems in automated systems
The Problem
For buyers supplying hospital dispensing systems or automated packaging lines, mask dimensions that drift between batches cause downstream operational problems.
Our Prevention
Our production lines use ultrasonic welding with fixed machine parameters — the 50,000th mask in your order is dimensionally identical to the first. Outgoing inspection includes dimensional verification on every batch.
Documentation Gaps at Customs
Shipment held at port due to incomplete paperwork
The Problem
A shipment that arrives without the correct test reports, certificates of conformity, or market-specific declarations gets held. We've seen this happen to buyers who switched to a lower-cost supplier and discovered the documentation package was incomplete only after the container arrived at port.
Our Prevention
Our export team prepares the full documentation package — test reports, CoC, packing lists, and any market-specific declarations — as a standard part of every shipment.
Why These Failures Persist in the Market
Each of these failure modes traces back to a structural gap: the supplier either doesn't control the critical input (meltblown fabric quality), doesn't invest in process controls (weld parameters, dimensional checks), or doesn't staff the export documentation function properly.
Vertical integration — owning the meltblown line, running fixed-parameter ultrasonic welding, and maintaining a dedicated export documentation team — eliminates these gaps at the source rather than catching them downstream.
Selecting the Right Surgical Mask Configuration for Your Market
Three product lines, multiple performance tiers, two major regulatory frameworks — here's how to match configuration to market requirement.
US Hospital or Clinical Accounts
Requirement: FDA 510(k) registered product.
General clinical use: ASTM F2100 Level 1 — BFE ≥95%, fluid resistance ≥80 mmHg. Covers most applications.
Surgical use / high-fluid-exposure: Level 2 (≥98% BFE, ≥120 mmHg) or Level 3 (≥98% BFE, ≥160 mmHg).
Recommended product:
3 Ply Medical Mask — covers all three ASTM levelsEU Healthcare Accounts
Requirement: CE (EU MDR) certification.
Surgical use standard: EN 14683 Type IIR — BFE ≥98%, splash resistance ≥120 mmHg.
Recommended products:
Both carry CE certification.
Operating Room or High-Risk Clinical Environments
Requirement: Both respiratory protection and barrier function simultaneously.
≥95% PFE at 0.3 microns combined with surgical-grade fluid resistance. This is the product for environments where both respiratory protection and barrier function are required simultaneously.
Recommended product:
N95 Surgical Medical MaskBuilding a Private-Label Program
Strategy: Start with the highest-volume configuration, then expand.
Core SKU: The Disposable Surgical Medical Mask — highest-volume configuration, most straightforward to package for retail or clinical distribution, and easiest to reorder consistently.
Expansion: Add the N95 or Level 2/3 configurations once your base program is established.
Start with:
Disposable Surgical Medical Mask
Quick Decision Framework
Identify your regulatory market (FDA/ASTM for US, CE/EN 14683 for EU)
Determine the clinical environment (general use vs. surgical/high-fluid vs. respiratory protection)
Match to the appropriate product line and performance tier
For private-label: start with the Disposable Surgical Medical Mask as your base, expand from there
Logistics, Container Loading, and Landed Cost
Surgical masks are a volume-sensitive product — container loading efficiency directly affects your landed cost per unit.
Standard Carton Configuration
Our flat-fold surgical masks pack at 2,000 pieces per carton (50 boxes × 40 pieces, or 10 boxes × 200 pieces depending on your packaging format).
These numbers assume standard retail or clinical packaging — bulk-packed configurations load more efficiently.
Packaging Designed for Container Efficiency
Carton dimensions are calculated to minimize dead space in standard container configurations. For buyers calculating landed cost, we provide exact CBM per carton and loading quantities for your specific packaging format before you confirm the order.
Lead Time
Standard SKUs run 15–25 days from order confirmation, depending on volume and current line scheduling. We give you a specific production completion date when we confirm the order — not a range.
EU MDR Documentation Support
For buyers new to importing medical devices into the EU: the MDR documentation requirements that took effect in 2021 added a technical file requirement that catches many first-time importers off guard. We've prepared the documentation package for multiple European buyers and can walk your compliance team through what's needed before you place the order.
Frequently Asked Questions
What is the minimum order quantity for surgical medical masks?
50,000 pieces for standard SKUs — disposable surgical, 3-ply, and N95 configurations. Custom packaging or non-standard configurations typically require a higher minimum; we'll confirm the MOQ when you specify the configuration. For buyers testing a new SKU, we can arrange sample orders before committing to full production.
What certifications are required to import surgical masks into the US and EU?
For the US:
FDA 510(k) registration is required for surgical masks classified as Class II medical devices. Our products carry FDA 510(k) registration, and we provide the registration documentation with every shipment.
For the EU:
CE certification under EU MDR (Medical Device Regulation 2017/745) is required. We hold CE (EU MDR) certification and can provide the technical file documentation your EU importer of record needs. Note that since MDR replaced MDD in May 2021, the technical file requirements are more extensive — if you're importing into the EU for the first time, contact us before placing the order.
What is the difference between ASTM F2100 Level 1, Level 2, and Level 3 surgical masks?
The three levels differ in fluid resistance and filtration efficiency:
| Level | BFE | Fluid Resistance | Typical Use |
|---|---|---|---|
| Level 1 | ≥95% | ≥80 mmHg | General clinical use — exam rooms, outpatient settings, low-fluid-exposure procedures |
| Level 2 | ≥98% | ≥120 mmHg | Moderate fluid exposure — most surgical procedures, emergency departments |
| Level 3 | ≥98% | ≥160 mmHg | High-fluid-exposure procedures — trauma surgery, significant aerosol or splash risk |
For most hospital supply programs, Level 2 is the standard specification. Level 1 is appropriate for general clinical and non-surgical use where cost per unit matters more than maximum fluid resistance.
How do you ensure BFE consistency across large orders?
We produce our own meltblown nonwoven fabric — the filtration layer that determines BFE performance. Every roll is batch-tested before entering production.
In-process QC runs BFE sampling at defined intervals on each production line. Outgoing inspection includes full BFE, PFE, and Delta-P testing on statistically sampled batches from every production run.
The test reports from outgoing inspection travel with your shipment. For orders over 1 million pieces, we can provide batch-level test reports covering the full production run.
Can you produce surgical masks with our brand packaging?
Yes. Standard OEM work — your brand on our existing product — requires artwork files, packaging spec confirmation, and a sample approval run before full production.
We handle private-label printing, retail-ready packaging, bulk clinical packaging, and individually wrapped configurations in-house. For custom packaging formats or modified product configurations, contact our team with your specifications and we'll confirm feasibility and MOQ.
What is the shelf life of your surgical masks, and how should they be stored?
Shelf life is 2 years from the production date, under standard storage conditions: temperature 10–30°C, relative humidity ≤80%, away from corrosive gases and direct sunlight.
Each carton is labeled with the production date and expiry date. For buyers managing inventory rotation in distribution programs, we can configure production scheduling to maximize remaining shelf life at the time of shipment.
Request a Quote or Discuss Your Requirements
If you know your target market and volume, send us those details and we'll come back with a specific product recommendation, pricing indication, and lead time.
If you're still evaluating configurations — deciding between ASTM levels, comparing packaging formats, or working out the compliance documentation for a new market — tell us where you are in the process and we'll work through it with you.
Most buyers in this category start with a sample order to verify spec and packaging before committing to a full container. We can arrange that.
Building 3, Zhilan Industrial Park, No. 88 Heng'er Road, Gaomi Economic Development Zone, Gaomi, Weifang, Shandong, 261500, China