Disposable Medical Masks From a Dedicated Factory
Certified disposable medical masks from a dedicated manufacturer — 13 years, one product category, one factory.
Three configurations covering standard clinical, high-filtration, and extended-wear applications. FDA 510(k) registered, CE (EU MDR) certified, ISO 13485:2016 quality system. In-house meltblown production means the filtration spec you order is the spec you receive.
What We Make and Why It Matters for Your Supply Chain
We've been manufacturing disposable medical masks since 2012 — not as a side line, not as a pandemic pivot, but as the core of what this factory does. Gaomi Eztio Medical Technology Co., Ltd. runs 6 fully automated production lines in a 12,000 m² facility in Shandong, China, producing 120 million pieces per year across three disposable mask configurations. The certifications — ISO 13485:2016, CE under EU MDR, FDA 510(k) registration, ISO 9001:2015, and SGS — cover the regulatory frameworks your buyers operate under in North America, Europe, the Middle East, and beyond.
Disposable medical masks are a commodity category in the sense that every supplier claims to make them. The sourcing risk isn't finding a factory — it's finding one where the BFE number on the spec sheet matches what's actually in the box. That gap exists because most mask factories buy meltblown nonwoven fabric from outside suppliers, which means their filtration performance is only as consistent as their fabric supplier's last delivery.
We produce our own meltblown fabric in-house. That single decision changes the risk profile of every order you place with us.
Three Disposable Medical Mask Configurations
Our disposable mask line covers the three configurations that account for the majority of institutional and distribution procurement. Each has a dedicated product page with full specifications, test data, and packaging options.
3 Ply Disposable Medical Mask
The standard SMS (spunbond-meltblown-spunbond) construction — outer spunbond layer for fluid resistance, meltblown core for filtration, inner spunbond layer for skin contact. BFE ≥95%, meets EN 14683 Type II and ASTM F2100 Level 1.
This is the configuration that moves in the highest volumes for general clinical use, pharmacy distribution, and institutional procurement. If your buyers are stocking hospital wards, outpatient clinics, or dental practices, this is the SKU that fits their procurement spec.
4 Ply Disposable Medical Mask
An SMMS construction (spunbond-meltblown-meltblown-spunbond) with a dual meltblown filtration layer, targeting BFE ≥98% and meeting EN 14683 Type IIR and ASTM F2100 Level 2. The additional meltblown layer adds filtration depth without meaningfully increasing Delta-P — breathability stays within clinical comfort range.
This configuration is the right answer for buyers supplying surgical environments, high-exposure clinical settings, or markets where Type IIR is the procurement standard. We run the 4-ply on a dedicated line — the dual meltblown layering requires precise tension control during lamination, and we don't mix it with 3-ply production.
Ear Loop Disposable Medical Mask
A 3-ply SMS mask with engineered ear-loop attachment, optimized for consistent fit and extended-wear durability. The ear loops are ultrasonically welded — not glued — so the attachment point doesn't degrade with humidity or prolonged use.
This configuration is the standard for workplace safety programs, retail pharmacy, and any application where the end user wears the mask for a full shift. Ear-loop tensile strength is tested at incoming inspection on every material lot; we pull to failure and reject any lot below 10N per loop.
Category-Wide Technical Specifications
These are the parameter ranges across our disposable medical mask line. Individual product pages carry the exact values for each configuration.
Construction & Performance
Materials & Dimensions
Standards & Logistics
View exact specifications per configuration:
In-House Meltblown Production: The Filtration Layer Under Our Control
This is the capability that separates our supply chain risk profile from most disposable medical mask manufacturers, and it's worth explaining in detail because it directly affects what you can promise your buyers.
Meltblown nonwoven fabric is the middle layer in every disposable medical mask — the layer that does the actual filtration work. It's produced by extruding polypropylene through fine nozzles at high velocity, creating a web of microfibers with diameters in the 1–5 micron range. The filtration performance of the finished mask — the BFE and PFE numbers on the spec sheet — is determined almost entirely by the meltblown layer: its basis weight, fiber diameter distribution, and electrostatic charge level. Change any of those parameters and the filtration number changes.
The Problem With Outsourced Meltblown
Most mask factories don't make their own meltblown. They buy it from fabric suppliers, and they test the incoming rolls against spec — but they're testing what arrived, not controlling what was made. When a fabric supplier has a bad production run, or when supply tightens and they start shipping rolls that are technically within tolerance but at the low end, the mask factory's BFE numbers drift.
The factory may not catch it until a third-party audit or a customs hold. We've seen this happen to competitors during supply disruptions — factories shipping product that passed their incoming inspection but failed the importer's independent testing. The problem wasn't fraud; it was that they had no visibility into the fabric production process.
How We Eliminate That Variable
We produce our own meltblown fabric. Our meltblown line runs at controlled parameters — fiber diameter, basis weight, and electrostatic treatment are set to match the filtration target for each mask configuration. When we produce a 3-ply mask rated at ≥95% BFE, the meltblown layer going into that mask was produced to that spec in our own facility, tested in our own lab, and approved before it entered the mask production line. The BFE number on your certificate of conformity reflects what's actually in the mask.
Why This Matters Commercially
Your buyers — whether they're hospital procurement teams, government tender evaluators, or retail pharmacy chains — are increasingly running independent verification testing on incoming product. A mask that passes your supplier's test but fails your buyer's test is a supply chain problem that lands on you. In-house meltblown production is how we eliminate that variable from your sourcing equation.
Meltblown Parameters We Control
Supply Chain Comparison
Buys meltblown from third-party suppliers. Tests incoming rolls but has no control over production parameters. BFE drift risk during supply disruptions.
Produces meltblown in-house. Controls fiber diameter, basis weight, and electrostatic treatment. Lab-tested before entering mask production. Certificate of conformity reflects actual mask content.
Certifications That Clear Customs and Pass Procurement Audits
Our certification stack covers the regulatory entry requirements for the markets you're most likely selling into.
ISO 13485:2016
Medical Device QMS
The baseline requirement for hospital and institutional procurement in most markets. This governs our entire production and QC process — not a certificate we maintain separately from how we operate.
CE (EU MDR)
European Market Access
European market access under the Medical Device Regulation. The MDR technical file requirements are significantly more demanding than the old MDD framework. We've maintained CE certification through the MDR transition, which means the documentation your EU importer of record needs is already prepared.
FDA 510(k) Registered
US Market Clearance
Your FDA import records reference our 510(k) registration number, which simplifies the customs entry process and reduces the risk of holds at the port of entry.
ISO 9001:2015
General Quality Management
General quality management system, covering the broader operational framework beyond medical-device-specific requirements.
SGS Verified
Third-Party Audit & Testing
Third-party audit and testing verification, providing independent confirmation of our production and testing claims.
Actively Maintained
All certifications are maintained through active surveillance audits — not obtained once and filed away. ISO 13485 surveillance runs annually, and FDA registration is kept current with production updates.
Importing into the EU for the first time since MDR came into force?
Since MDR came into force in 2021, the 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.
When you request our compliance documentation package, you're getting current certificates, not copies from three years ago.
Market Segments Where Disposable Medical Masks Move at Volume
Disposable medical masks are not a single-channel product. The buyers we supply are operating in distinct market segments with different procurement cycles, volume patterns, and compliance requirements — and understanding which segment you're serving determines which configuration and documentation package you need.
Hospital & Clinical Supply Chains
Annual / Multi-Year Contracts
Run on annual or multi-year procurement contracts, typically through GPOs or direct institutional tender. Volume per contract ranges from hundreds of thousands to tens of millions of pieces.
Compliance bar: ISO 13485 certification and independent BFE test reports are standard requirements. Some hospital systems now require facility audits. Our documentation package is built for this procurement environment.
Private-Label Healthcare Brands
OEM / Branded Product
Building margin on branded product rather than competing on commodity price. The value here is OEM packaging capability — your brand on a certified, consistently performing product.
How we support: We handle private-label programs in-house, from artwork files through sample approval to full production. The 50,000-piece MOQ on standard SKUs is accessible for market-entry programs, and we scale with you as your brand grows.
Government & Emergency Stockpiling
Supply Reliability Priority
Prioritize supply reliability and documentation completeness over unit price. These buyers need to know that a 10-million-piece order will ship on schedule and arrive with the compliance documentation that satisfies their procurement audit.
Capacity assurance: Our 120-million-piece annual capacity means a large government order doesn't require us to restructure our production schedule.
Pharmacy & Retail Distribution
Shelf-Ready Packaging
Need shelf-ready packaging and consistent product appearance across batches. Color consistency on the outer layer, packaging that survives retail handling, and labeling that meets your market's language and regulatory requirements.
In-house capability: We produce retail-ready packaging in-house — these are the details that matter for retail placement.
Industrial & Workplace Safety Programs
Recurring PPE VolumeManufacturing facilities, construction sites, food processing plants — procure disposable masks as PPE under occupational health requirements. Volume is predictable and recurring, driven by headcount and shift schedules rather than seasonal demand.
OEM and Private-Label: Your Brand on Certified Product
Standard OEM work — your brand on our existing product configurations — is straightforward. You provide artwork files and packaging specifications; we produce a sample run for your approval, then move to full production. The certification documentation travels with the product regardless of whose brand is on the box, because the certifications are tied to the product and manufacturing process, not the label.
ODM projects — modified configurations, different filtration targets, custom mask dimensions, or new packaging formats — go through our product development process. We have the in-house capability to adjust meltblown parameters for different filtration targets, modify ear-loop configurations, and develop new packaging formats. Custom configurations typically require a higher minimum than our standard 50,000-piece MOQ to justify the line setup and material procurement. We'll confirm the actual minimum for your specific configuration before you commit to sample development.
Consistency Across Reorders
The practical advantage of OEM with a factory that controls its own meltblown production: your private-label product's filtration performance is consistent across reorders. You're not dependent on whether your supplier's fabric vendor shipped the same quality roll this quarter as last quarter. That consistency is what protects your brand's reputation with your downstream buyers.
Standard OEM
Your brand on our existing product configurations.
- You provide artwork files + packaging specs
- Sample run for approval before full production
- Certifications travel with the product
- Standard 50,000-piece MOQ
ODM / Custom Configuration
Modified configurations developed through our product development process.
- Adjusted meltblown parameters for different filtration targets
- Modified ear-loop configurations
- Custom mask dimensions + new packaging formats
- Higher MOQ confirmed before sample development
Packaging, Container Loading, and Landed Cost
Standard carton configuration: 50 pieces per box, 40 boxes per master carton (2,000 pieces per master carton). Carton dimensions are designed for container efficiency — a 40HQ container loads approximately 4,000–4,500 master cartons, or 8–9 million pieces, depending on configuration. For buyers calculating landed cost per unit, this loading density is a meaningful variable.
Packaging Options Across the Product Line
Bulk Clinical Packaging
50 pcs/box, plain or branded, for hospital and institutional use.
Retail Shelf-Ready Packaging
Individual or multi-pack formats with retail-compliant labeling.
Private-Label Packaging
Custom artwork, language variants, market-specific regulatory text.
Export Documentation
Prepared with every shipment:
- Certificate of conformity
- BFE/PFE/Delta-P test reports
- Packing list & commercial invoice
- Market-specific declarations for customs/compliance
Lead Time on Standard SKUs
We give you a specific production completion date when we confirm your order — not a range that shifts based on line scheduling.
What Goes Wrong with Disposable Mask Sourcing — and How We Prevent It
The disposable medical mask category has well-documented failure modes. Buyers who have been sourcing long enough have encountered most of them.
BFE Drift Between Orders
The problem: A supplier's first shipment tests at 97% BFE. The third shipment tests at 93%. Nothing changed on the spec sheet. What changed was the meltblown fabric — a different production run from the fabric supplier, slightly different fiber diameter distribution, slightly lower electrostatic charge. The mask factory's incoming inspection passed it because it was within their acceptance tolerance. Your buyer's independent test caught it.
Our fix: In-house meltblown production with batch-level testing before the fabric enters the mask line. We test every meltblown batch in our own lab before it goes into production.
Ear-Loop Failure in the Field
The problem: The most common complaint in the disposable mask category is ear-loop detachment — loops that pull free after a few hours of wear, or that break at the attachment point. This happens when ear loops are attached with adhesive rather than ultrasonic welding, or when welding parameters aren't controlled tightly enough.
Our fix: Our production lines use ultrasonic welding for all ear-loop attachment, with weld parameters set and verified at the start of each production run.
Nose Wire Corrosion in Humid Climates
The problem: Aluminum nose wires are standard, but the alloy grade and surface treatment vary. Low-grade aluminum wire corrodes in humid storage conditions, leaving oxidation marks on the mask and triggering returns.
Our fix: We specify corrosion-resistant aluminum alloy for all nose wire, and incoming inspection includes a humidity exposure check on each lot.
Documentation Gaps at Customs
The problem: A shipment that arrives without the right compliance documentation — missing test reports, expired certificates, incorrect declarations — gets held at the port. The cost of a customs hold on a medical supply shipment is not just the demurrage; it's the downstream supply disruption for your buyer.
Our fix: We prepare the full documentation package before the shipment leaves our facility, and our export team has handled FDA, EU MDR, and Gulf market documentation requirements across hundreds of shipments.
Frequently Asked Questions
What is the minimum order quantity for disposable medical masks?
50,000 pieces for standard SKUs — 3-ply, 4-ply, and ear-loop configurations in standard packaging. Custom configurations (modified dimensions, non-standard packaging, new private-label artwork) typically require a higher minimum to cover line setup and material procurement. We'll confirm the actual minimum for your specific configuration before you commit to sample development.
What is the difference between 3-ply and 4-ply disposable medical masks, and when does the upgrade matter?
The 3-ply SMS construction targets BFE ≥95% and meets EN 14683 Type II / ASTM F2100 Level 1 — the standard for general clinical use, outpatient settings, and most institutional procurement.
The 4-ply SMMS construction adds a second meltblown layer, targeting BFE ≥98% and meeting EN 14683 Type IIR / ASTM F2100 Level 2. The upgrade matters when your buyers are supplying surgical environments, high-exposure clinical settings, or markets where Type IIR is the procurement standard.
For general distribution and workplace safety programs, the 3-ply is the right spec — the 4-ply adds cost without adding value for those applications.
How do I verify that a disposable medical mask supplier's BFE claims are accurate?
Request the test reports, not just the certificates. A BFE certificate tells you the product was tested; the test report tells you the actual measured value, the test method, the sample size, and the testing lab. Look for reports from accredited third-party labs (Nelson Labs, SGS, Intertek, Bureau Veritas) rather than in-house testing only.
Then ask whether the supplier produces their own meltblown fabric — if they don't, ask how they verify incoming fabric quality and what their batch-to-batch BFE variance looks like across the last 12 months. A supplier who can answer that question with data is a supplier whose BFE claims are worth trusting.
What certifications are required to import disposable medical masks into the EU?
Under EU MDR (Regulation 2017/745), disposable medical masks classified as Class I medical devices require CE marking with a Declaration of Conformity and a technical file maintained by the manufacturer. The importer of record in the EU must be registered in EUDAMED.
Since May 2021, the MDR requirements have replaced the old MDD framework, and the documentation requirements are more extensive — particularly around clinical evaluation and post-market surveillance. Our CE certification is maintained under MDR, and we provide the Declaration of Conformity and technical file summary with every EU shipment.
Does the meltblown fabric source affect BFE performance, and how can I check?
Yes — meltblown fabric quality is the primary determinant of BFE performance. The key variables are fiber diameter (finer fibers = higher filtration), basis weight (heavier = more filtration depth), and electrostatic charge level (charge significantly boosts filtration efficiency without increasing Delta-P).
A supplier who buys meltblown from outside has limited visibility into these parameters — they can test the incoming roll, but they can't control the production process. Ask your supplier for batch-level BFE test data across their last 10 production runs. If the numbers are consistent within ±1–2%, their meltblown supply is stable. If the numbers vary by 3–5% or more, you're looking at a fabric supply consistency problem that will eventually show up in your buyers' independent testing.
What is the lead time for a standard disposable medical mask order?
15–25 days from order confirmation for standard SKUs, depending on order volume and current line scheduling. We give you a specific production completion date when we confirm your order. For new buyers, we recommend starting with a sample order to verify specs and packaging before committing to full production volume — samples ship within 5–7 business days.
Ready to Source Disposable Medical Masks?
Send us your target configuration, volume, and destination market — we'll come back with a specific quote, current test reports, and a production timeline.
If you're evaluating us against other suppliers, ask for our batch-level BFE data from the last six months. That's the number that tells you whether the spec sheet reflects what's actually in the box.
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