About eztio
Gaomi Eztio Medical Technology Co., Ltd. — a dedicated disposable medical mask manufacturer based in Gaomi, Shandong, China. Since 2012, we have built one business and one business only: producing certified medical-grade masks for overseas buyers.
What We Do and Who We Supply
Distributors, healthcare procurement teams, and private-label brands who need a factory they can rely on across multiple order cycles — not just one.
Our facility covers 12,000 square meters in the Zhilan Industrial Park, Gaomi Economic Development Zone. We run 6 fully automated production lines, employ 150 people, and ship 120 million pieces per year. The certifications on our products — ISO 13485:2016, CE under EU MDR, FDA 510(k) registration, ISO 9001:2015, and SGS — are not decorative. They are the entry ticket to the markets you sell into, and we maintain them because our buyers need them to clear customs and pass procurement audits.
We supply North America, Europe, the Middle East, Southeast Asia, and Africa. Most of our buyers are not buying for themselves — they are stocking hospital supply chains, building private-label healthcare brands, or fulfilling government and institutional tenders. That context shapes how we work: consistent specs across batches, documentation that survives compliance review, and packaging that can carry your brand without modification.
Healthcare Procurement
Stocking hospital supply chains with documentation that survives compliance review and procurement audits.
Private-Label Brands
Packaging that can carry your brand without modification, consistent specs across batches for brand reliability.
Distributors
A factory you can rely on across multiple order cycles with repeatable quality and delivery schedules.
Government & Institutional Tenders
Full certification documentation and batch traceability for public procurement requirements.
Active Certifications
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ISO 13485:2016Medical device quality management
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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 system
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SGS VerifiedThird-party inspection
Export Markets
How We Got Here
From a small nonwoven products operation to a vertically integrated medical mask manufacturer with in-house meltblown capacity.
Founded as Nonwoven Products Operation
We started in 2012 as a small nonwoven products operation. The early years were straightforward contract manufacturing — standard 3-ply masks, basic ear-loop configurations, domestic and regional buyers.
ISO 13485 Certification — QC Infrastructure Rebuilt
The real inflection point came when we started pursuing export certification. ISO 13485 is a different discipline from ISO 9001 — it demands documented risk management, design controls, and traceability at a level that forces you to rebuild your QC infrastructure from scratch. We did that work between 2015 and 2017, and it changed how the factory operates at every level.
In-House Meltblown Production
The second shift was vertical integration. Meltblown nonwoven fabric — the filtration layer that determines whether a mask actually performs — is the component that most mask factories buy from outside suppliers. We brought that production in-house.
Why Meltblown Matters
During periods of supply disruption, factories without their own meltblown capacity either stop shipping or ship masks that don't meet BFE specs. We've seen both happen to competitors.
By controlling our own meltblown output, we control the one variable that determines filtration performance, and we can guarantee spec consistency across your entire order.
What This Means for Buyers
- No supply interruptions from upstream meltblown shortages
- BFE spec consistency guaranteed across your entire order
- Full traceability from raw material to finished product
- ISO 13485-level risk management and design controls at every stage
Inside the Facility: 12,000 m² Built for Medical-Grade Output
Walk through our production building and the first thing you notice is the cleanroom. Our core mask production runs in a Class 100,000 (ISO 8) cleanroom environment — particle counts are monitored continuously, and access is controlled. For medical devices, this isn't optional; it's what separates a product that passes regulatory review from one that doesn't.
6 Fully Automated Lines with Ultrasonic Welding
The 6 production lines are fully automated, using ultrasonic welding technology for nose wire embedding, ear-loop attachment, and edge sealing. Ultrasonic welding eliminates adhesive variability — the bond strength is determined by the machine parameters, not by operator technique, so the 50,000th mask in your order is structurally identical to the first.
Each line runs at a fixed output rate, which means we can give you a delivery date and hold it. A 5-million-piece order doesn't require us to improvise.
In-House Meltblown Nonwoven Production
Meltblown fabric is the middle layer — the one that does the actual filtration work. We produce it ourselves, which means we set the fiber diameter, the basis weight, and the electrostatic charge level to match the filtration spec we're targeting.
When you order a mask rated at ≥95% BFE, we're not hoping the fabric supplier shipped the right roll. We know what's in the mask because we made the material.
In-House QC Laboratory
Our in-house QC lab runs BFE (Bacterial Filtration Efficiency), PFE (Particulate Filtration Efficiency), and Delta-P (breathability/pressure differential) testing on every production batch. These are the three performance parameters that determine whether a mask meets ASTM F2100, EN 14683, or equivalent standards.
We test in-house first, then submit to third-party labs for certification documentation. The in-house testing catches problems before they become shipment problems — a batch that fails internal BFE testing gets pulled and investigated before it ever reaches the outgoing inspection stage.
Core Production Capabilities
ISO 8 Cleanroom
Class 100,000 cleanroom manufacturing environment with continuous particle monitoring and controlled access.
6 Automated Lines
Fully automated production lines with ultrasonic welding for consistent bond strength across every unit.
In-House Meltblown
Own meltblown nonwoven fabric production — fiber diameter, basis weight, and electrostatic charge controlled internally.
BFE / PFE / Delta-P Lab
In-house testing laboratory for bacterial filtration efficiency, particulate filtration efficiency, and breathability.
120M Annual Capacity
120,000,000 pieces per year. Fixed output rates per line enable reliable delivery commitments on large orders.
Full Product Range
3-ply surgical masks, N95 respirators, 4-ply disposable masks, ear-loop and tie-on configurations.
Certifications and the QC Process Behind Them
Certifications tell you what the system is designed to do. The QC process tells you whether it actually does it. Ours runs in three stages.
Three-Stage Quality Control Process
Incoming Inspection
Every raw material lot is tested against spec before it enters production. Problems are caught at the dock, not discovered after the masks are made.
In-Process Inspection
Runs at defined intervals on each production 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.
ISO 13485 discipline: The line stops, the cause is identified, and production resumes only after the parameter is corrected. This is built into the standard operating procedure.
Outgoing Inspection
The final gate before packaging and shipment. A statistically sampled batch from each production run goes through full performance testing.
Documentation: Test reports from this stage travel with your shipment and support your import documentation.
Environmental Practices and Worker Standards
Our production generates two primary waste streams: nonwoven fabric trim and rejected product. Both are managed through documented processes that keep material out of landfill and out of the supply chain where it doesn't belong.
Fabric Trim Recycling
Nonwoven fabric trim from the cutting and welding process is collected, baled, and sent to certified recycling processors. It doesn't go to landfill.
Rejected Product Handling
Rejected masks that fail QC are segregated, documented, and destroyed under controlled conditions. They don't re-enter the supply chain.
Energy & Cleanroom HVAC
The cleanroom environment requires HVAC systems that run continuously. We've invested in energy-efficient filtration units that maintain ISO 8 particle counts at lower power draw than older systems.
Worker Safety Protocols
Worker safety in our facility follows standard PPE protocols for nonwoven dust exposure. All production staff rotate through documented safety training on a scheduled basis.
We don't have an ISO 14001 certification to point to, but the practices are in place because they're operationally necessary — a cleanroom that isn't properly maintained stops being a cleanroom.
Custom Development and OEM/ODM Capability
Our engineering team handles OEM and ODM projects directly — custom packaging, private-label printing, modified mask configurations, and new SKU development.
OEM — Your Brand, Our Product
Private Label
For standard OEM work — your brand on our existing product — the process is straightforward:
- 1 Artwork files submitted
- 2 Packaging spec confirmation
- 3 Sample approval run before full production
ODM — Modified or New Product
Custom Development
ODM projects — where you need a modified product, a different filtration spec, or a configuration we don't currently run — go through our product development process.
In-House Capabilities
- Adjust meltblown parameters for different filtration targets
- Modify ear-loop configurations
- Develop new packaging formats
The People Running the Lines
The technical decisions at eztio are made by people who have been in this industry long enough to have made the expensive mistakes already. Our production director has over 15 years in disposable medical product manufacturing, with direct experience managing cleanroom operations and regulatory audits. Our QC lead has a background in medical device inspection and has managed the ISO 13485 surveillance audit process through multiple certification cycles. The meltblown production team — the group that actually controls the filtration layer — includes engineers who have been working with nonwoven extrusion processes for more than a decade.
We're 150 people. That's not a large organization, which means the people with the technical knowledge are close to the production floor, not three management layers away from it.
15+ years in disposable medical product manufacturing, cleanroom ops & regulatory audits
Medical device inspection background, managed ISO 13485 surveillance through multiple cycles
Engineers with 10+ years in nonwoven extrusion processes controlling the filtration layer
Shipping to North America, Europe, and Beyond
We export to North America, Europe, the Middle East, Southeast Asia, and Africa. The documentation requirements vary significantly by market — and we've handled all of them.
Market-Specific Documentation
FDA import records and compliance documentation
CE technical files and MDR documentation packages
SFDA equivalents and regional compliance declarations
Market-specific declarations and customs documentation
Full Documentation Package
Our export team prepares the complete documentation package: certificate of conformity, test reports, packing lists, and any market-specific declarations your customs broker or compliance team needs.
Container-Optimized Packaging
Packaging is configured for container efficiency. Standard carton sizes are designed to maximize 20GP and 40HQ loading without wasted cubic space — this matters when you're calculating landed cost per unit.
For buyers building private-label programs, we can produce shelf-ready retail packaging or bulk clinical packaging depending on your downstream channel. Lead time on standard SKUs runs 15–25 days from order confirmation, depending on order volume and current line scheduling. We'll give you a specific date, not a range, once we confirm your order.
EU Importers: MDR Documentation Note
If you're importing into the EU for the first time, the MDR documentation requirements have caught a lot of buyers off guard since 2021. 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.
Discuss EU import requirementsSix Reasons to Source from eztio
Vertically integrated manufacturing, regulatory readiness, and flexible order structures built for professional importers and distributors.
In-House Meltblown Production
We manufacture the filtration layer ourselves, so BFE and PFE specs are controlled at the source — not dependent on a third-party fabric supplier's consistency.
FDA 510(k) + CE (EU MDR) Registered
Your shipments arrive with the regulatory clearance already in place for the two most demanding import markets, reducing your compliance risk on every order.
Class 100,000 Cleanroom Manufacturing
Medical-grade production environment with continuous particle monitoring, so your product meets the facility standards required by hospital and institutional procurement.
50,000-Piece MOQ on Standard SKUs
Flexible enough for market-entry orders and trial programs, without forcing you to commit to volumes that don't match your current demand.
Full OEM/ODM Packaging Capability
Private-label programs, custom configurations, and retail-ready packaging handled in-house, so your brand goes to market without a separate packaging supplier in the chain.
Complete Export Documentation
Test reports, certificates of conformity, and market-specific compliance documents prepared with every shipment, so your import process runs without delays at customs.
Contact eztio
Ready to discuss your sourcing requirements or request samples? Reach us directly through any of the channels below.
Building 3, Zhilan Industrial Park, No. 88 Heng'er Road, Gaomi Economic Development Zone, Gaomi, Weifang, Shandong, 261500, China
Start Your Sourcing Conversation
Whether you need samples for qualification, pricing for a specific volume tier, or technical documentation for your regulatory submission — our export team responds within one business day.