Medical Mask Manufacturer With the Certifications Your Markets Require
ISO 13485:2016, CE (EU MDR), and FDA 510(k) registered. Factory-direct medical masks shipped from our 12,000 m² facility in Shandong, China.
Our Medical Mask & PPE Product Lines
We manufacture across five product categories, each with multiple SKU configurations to match your downstream channel requirements.
Surgical Medical Masks
Our core product line — 3-ply and N95 surgical configurations built to ASTM F2100 and EN 14683 standards. Ear-loop and tie-on configurations available, with BFE ≥98% on standard surgical grades.
Built for hospital procurement, pharmacy distribution, and institutional supply contracts. If you're building a healthcare distribution catalog, this is where most buyers start.
Disposable Medical Masks
3-ply, 4-ply, and ear-loop configurations for general medical and clinical use. The 4-ply variant adds an additional meltblown layer for buyers targeting higher-filtration segments.
Useful when your customers are comparing specs and you need a product that stands out on paper. High-volume SKUs with container-optimized carton sizing for efficient landed cost.
N95 Medical Masks
Disposable and hospital-grade N95 respirators for buyers supplying healthcare facilities, emergency response programs, or government stockpile tenders. FDA 510(k) clearance covers these products for US import.
Buyers in this category typically run larger minimum orders and longer-term supply agreements — the compliance documentation we provide is built for that kind of procurement scrutiny.
Medical Protective Clothing
Disposable protective clothing, isolation gowns, and coveralls for clinical and industrial PPE programs.
These products complement mask orders for buyers building full PPE bundles — a single supplier for masks and protective clothing simplifies your procurement and consolidates your compliance documentation.
Medical Caps
Disposable caps, bouffant caps, and surgical caps for operating room and clinical environments.
Steady-reorder products with predictable demand cycles — hospitals and surgical centers replenish on fixed schedules, which makes this a reliable volume category for distributors with healthcare accounts.
In-House Meltblown Production: The Variable Most Factories Can't Control
The filtration layer in a medical mask — the meltblown nonwoven fabric sandwiched between the outer and inner layers — is what determines whether the mask actually performs to spec. Most mask factories buy this material from outside suppliers. We produce it ourselves, and that distinction has real consequences for your orders.
The Risk of External Meltblown Sourcing
When you source from a factory that purchases meltblown externally, their BFE and PFE performance is only as consistent as their fabric supplier's last production run. Fiber diameter, basis weight, and electrostatic charge level all affect filtration efficiency, and none of those parameters are visible on a roll of fabric. We've seen what happens when a supplier's meltblown source changes without notice — the masks look identical, but the filtration numbers shift. That's a compliance problem that lands on your import documentation, not theirs.
How In-House Production Solves This
Because we run our own meltblown extrusion line, we set those parameters ourselves. When we target ≥95% BFE on a standard surgical mask, we're controlling the fiber diameter and charge density at the source — not relying on a certificate of conformity from a third party. Every production batch goes through in-house BFE and PFE testing before it reaches outgoing inspection, so we catch any drift before it becomes a shipment problem.
For buyers who have had a compliance rejection or a failed audit because of inconsistent filtration performance, this is the structural difference that prevents it from happening again.
We brought meltblown production in-house between 2015 and 2017, partly because of what we saw happen to competitors during supply disruptions. Factories without their own meltblown capacity either stopped shipping or shipped product that didn't meet spec. We decided that wasn't a risk we were willing to pass on to our buyers.
Parameters We Control
- Fiber diameter specification
- Basis weight consistency
- Electrostatic charge density
- In-house BFE & PFE testing per batch
FDA 510(k) + CE (EU MDR): Market Access Already Cleared
Getting a medical mask into the US or EU isn't just a matter of finding a factory with the right certifications on their wall. The FDA 510(k) clearance process requires documented substantial equivalence to a predicate device, and the EU MDR framework — which replaced the older MDD in 2021 — demands a full technical file, clinical evaluation, and a notified body review. We've been through both processes. Our products carry FDA 510(k) registration for US import and CE marking under EU MDR for European market access.
What this means for your supply chain: your shipments arrive with the regulatory clearance already in place. Your customs broker gets the documentation they need. Your institutional buyers — hospitals, government procurement offices, group purchasing organizations — get the compliance records their auditors require.
Full Export Documentation Package
We prepare the full export documentation package with every shipment:
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Certificate of conformity
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Test reports
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Packing lists
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Market-specific declarations your importer of record needs
For buyers entering the EU market for the first time, the MDR documentation requirements have caught a lot of importers off guard since 2021 — we've walked multiple European customers through exactly what their importer of record needs before the order ships.
OEM/ODM Packaging: Your Brand, Our Production
Private-label programs are handled in-house — custom packaging artwork, retail-ready box formats, bulk clinical packaging, and modified mask configurations. Your brand goes to market without a separate packaging supplier in the chain, which removes one more coordination point and one more potential delay.
OEM (Standard Private Label)
For standard OEM work, the process is straightforward:
50,000 pieces — flexible enough for market-entry programs and trial orders.
ODM (Custom Development)
ODM projects — custom filtration specs, modified ear-loop configurations, new SKU development — go through our product development process.
Because we control meltblown production, we can adjust filtration parameters for different performance targets without sourcing a new fabric supplier.
Custom configurations require a higher minimum to justify line setup and material procurement — we'll tell you that upfront, before you've invested in sample approval.
50,000-Piece MOQ: Entry-Level Volume Without Commodity Pricing
Most certified medical mask factories set MOQs that only make sense for buyers already running established distribution programs. We set our standard SKU MOQ at 50,000 pieces — low enough for market-entry orders, trial programs, and new SKU launches, without forcing you to commit to volumes that don't match your current demand.
For buyers testing a new market or adding a product line, this is the difference between being able to run a real trial and having to guess at volume before you have sales data.
Market Trial Orders
Test new SKUs or geographies without overcommitting inventory.
New Product Launches
Add a product line with real production quality, not sample-grade guesswork.
Production Capacity and QC Infrastructure
Six fully automated production lines in a Class 100,000 (ISO 8) cleanroom environment, delivering structural consistency from the first mask to the 500,000th.
Ultrasonic Welding Technology
Nose wire embedding, ear-loop attachment, and edge sealing via ultrasonic welding. Bond strength is set by machine parameters, not operator technique — eliminating adhesive variability across your entire order.
ISO 8 Cleanroom Environment
Class 100,000 cleanroom with controlled particulate levels throughout the production floor. Environmental consistency ensures filtration media integrity from raw material handling through final packaging.
120M Annual Capacity
Annual output capacity of 120 million pieces. A 5-million-piece order doesn't require rescheduling other customers — your timeline stays intact regardless of order size.
In-House QC Lab: BFE, PFE, and Delta-P Testing
Our in-house QC lab runs BFE, PFE, and Delta-P testing on every production batch — these are the three performance parameters that determine ASTM F2100 and EN 14683 compliance.
In-house testing catches problems before they become shipment problems. A batch that fails internal BFE testing gets pulled and investigated before it reaches outgoing inspection. We then submit to third-party labs for the certification documentation that travels with your shipment.
Market Segments Where Medical Masks Generate Repeat Volume
Medical masks aren't a one-time purchase in any of the segments below — they're consumables with predictable reorder cycles. Here's where our buyers are building profitable distribution programs.
Hospital and Clinical Supply Chains
Hospitals and surgical centers run on fixed procurement schedules — quarterly or annual tenders for surgical masks, N95 respirators, and procedure masks. Order sizes typically run 500,000 to several million pieces per contract, and the compliance requirements (ISO 13485, FDA 510(k), CE MDR) are non-negotiable entry criteria.
Buyers who can deliver certified product consistently win multi-year supply agreements. Our documentation package is built specifically for this procurement environment.
View surgical masksGovernment and Institutional Stockpile Programs
Emergency management agencies, military medical units, and national health authorities periodically build or replenish strategic reserves. These tenders are large — often 10 million pieces or more — and they move fast when they open.
The buyers who win them are the ones with certified suppliers already qualified and on file. FDA 510(k) and CE MDR clearance are standard requirements for US and EU government procurement.
View N95 masksHealthcare Distributor Private-Label Programs
Distributors building their own branded PPE lines need a factory that can handle OEM packaging without adding a third-party packaging supplier to the chain. The margin structure on private-label medical masks is meaningfully better than reselling a branded product — and the reorder dynamic is strong once your brand is established in a hospital or clinic network.
MOQ at 50,000 pieces makes it viable to launch a new SKU without a large upfront commitment.
OEM/ODM servicesPharmacy and Retail Healthcare Chains
Pharmacy chains and health retailers stock surgical and disposable masks as year-round SKUs, with demand spikes during respiratory illness seasons. Retail-ready packaging, consistent spec across reorders, and reliable lead times are the three things that keep a pharmacy buyer coming back.
We produce shelf-ready retail packaging in-house, and our batch-to-batch consistency is backed by in-house BFE testing on every production run.
View disposable masksIndustrial and Occupational Health Programs
Manufacturing facilities, construction companies, and logistics operators source disposable masks for worker health programs — often through occupational health distributors or safety equipment suppliers.
These buyers prioritize price-per-unit and reliable supply over premium certification stacks, making our 3-ply disposable line the right fit. Volume is steady and reorders are predictable once you're on a facility's approved supplier list.
View disposable masksFull PPE Bundle Distribution
Buyers supplying hospitals, clinics, or industrial facilities increasingly want a single supplier for masks, protective clothing, and caps — it simplifies procurement, consolidates compliance documentation, and reduces the number of supplier relationships to manage.
Our product range covers masks, isolation gowns, coveralls, and surgical caps, so you can build a complete PPE catalog from one source.
View protective clothingReady to Discuss Your Sourcing Requirements?
Tell us your target market, volume expectations, and whether you need OEM packaging — we'll come back with a specific product recommendation and a quote based on what's actually moving for our buyers in that region.