N95 Surgical Medical Mask Factory-Direct
≥95% particulate filtration, fluid resistance, and full surgical-grade compliance — manufactured in-house from meltblown fabric to finished unit.
FDA 510(k) registered, CE (EU MDR) certified, and produced in a Class 100,000 cleanroom. Every batch is BFE/PFE/Delta-P tested before it ships. Your downstream customers get a product that clears customs and passes procurement audits.
What Makes This an N95 Surgical Mask — and Why the Distinction Matters for Your Market
Most masks on the market are one or the other: an N95 respirator that meets NIOSH particulate filtration requirements, or a surgical mask that meets ASTM F2100 fluid resistance and bacterial filtration standards. An N95 surgical medical mask has to clear both bars simultaneously — ≥95% PFE against non-oil-based particles and the fluid resistance and BFE performance required for surgical environments. That dual compliance is what makes this product harder to manufacture and more valuable to sell.
The buyers who need this specific product are supplying operating rooms, ICUs, and high-acuity clinical settings where airborne pathogen exposure and fluid splash are both real risks. Hospital procurement teams and government tender specifications increasingly require the combined rating because it eliminates the need to manage two separate SKUs for the same clinical environment. For your distribution business, that means a product with a defensible premium over standard surgical masks and a customer base — hospital systems, healthcare GPOs, government health agencies — that buys on contract and reorders predictably.
We produce this mask at our 12,000 m² facility in Gaomi, Shandong, running 6 fully automated production lines in a Class 100,000 (ISO 8) cleanroom. The filtration layer — the meltblown nonwoven fabric that determines whether the mask actually hits ≥95% PFE — is produced in-house. We set the fiber diameter, basis weight, and electrostatic charge ourselves. When you order a mask rated at ≥95% PFE, we're not relying on a third-party fabric supplier's batch consistency. We know what's in the mask because we made the material.
Dual Compliance
NIOSH 42 CFR Part 84 particulate filtration + ASTM F2100 surgical-grade fluid resistance in a single SKU.
Target Buyers
Hospital systems, healthcare GPOs, government health agencies — contract-based, predictable reorder cycles.
In-House Meltblown
Fiber diameter, basis weight, and electrostatic charge controlled at source — no third-party fabric dependency.
Technical Specifications
The table below reflects industry-standard parameters for N95 surgical medical masks meeting NIOSH 42 CFR Part 84 and ASTM F2100 Level 2/3 requirements. Confirm exact specifications for your order via inquiry.
| Parameter | Specification |
|---|---|
| Filtration Standard | NIOSH 42 CFR Part 84 (N95 class) |
| Particulate Filtration Efficiency (PFE) | ≥95% (0.3 μm NaCl aerosol) |
| Bacterial Filtration Efficiency (BFE) | ≥98% (ASTM F2101) |
| Fluid Resistance | ≥120 mmHg (ASTM F1862) |
| Differential Pressure (Delta-P) | ≤5.0 mm H₂O/cm² |
| Layers | 5-layer construction (spunbond / meltblown / meltblown / spunbond / inner comfort layer) |
| Nose Wire | Dual aluminum nose wire, corrosion-resistant |
| Ear Loop / Head Strap | Adjustable head strap (standard) or ear-loop configuration (OEM option) |
| Fit Type | Cup-shaped / flat-fold (specify at order) |
| Color | White (standard); custom colors available on OEM runs |
| Packaging | 10 pcs/inner box, 200 pcs/carton (standard); custom packaging available |
| Shelf Life | 3 years from production date |
| Certifications | FDA 510(k) Registered, CE (EU MDR), ISO 13485:2016, ISO 9001:2015, SGS |
Specifications shown are industry-standard values for this product type. Actual specifications may vary by configuration. Contact us for detailed product data sheets and test reports.
A Note on Delta-P
We run our meltblown at a basis weight that keeps breathability within the ≤5.0 mm H₂O/cm² threshold without sacrificing filtration. Some factories push the meltblown density to hit PFE numbers and end up with masks that technically pass filtration but fail Delta-P. We've seen that happen with competitor product in the field — it's the kind of failure that generates returns and compliance complaints.
In-House Meltblown Production: The Filtration Layer We Control Ourselves
The meltblown nonwoven fabric is the middle layer — the one that does the actual filtration work. For most mask factories, it's a purchased input. They buy rolls from a fabric supplier, run them through their production lines, and hope the batch-to-batch consistency holds. When it doesn't — and during periods of supply disruption or high demand, it often doesn't — the masks that come off the line may not hit the PFE spec they're supposed to hit.
We brought meltblown production in-house specifically to eliminate that variable. Our meltblown team controls fiber diameter (typically 1–5 μm for N95-grade filtration), basis weight, and the electrostatic charging process that gives the fabric its filtration performance. When we set a target of ≥95% PFE, we're adjusting our own production parameters to hit it — not calling a supplier and hoping the next delivery matches the last one.
What This Means for Your Sourcing Operation
Spec Consistency Across Your Entire Order
The 500,000th mask in a large order has the same filtration performance as the first, because the meltblown fabric came from the same controlled production run. No batch-to-batch variance from external suppliers.
Supply Chain Resilience
When global meltblown supply tightens — as it did dramatically in 2020 and has done in smaller cycles since — we don't stop shipping. We adjust our own production schedule. Buyers who sourced from factories without in-house meltblown capacity learned this distinction the hard way.
Controlled Production Parameters
Regulatory Clearance for Your Target Markets
The N95 surgical medical mask carries the full certification stack your buyers need to clear customs and pass procurement audits in the markets you're selling into.
FDA 510(k) Registered
FDA 510(k) clearance is the entry requirement for surgical masks sold into US healthcare channels. Without it, your product cannot be sold to hospitals, healthcare systems, or government health agencies. Our registration covers this product, so your import documentation is clean from day one.
CE (EU MDR)
CE marking under the EU Medical Device Regulation is required for surgical masks sold in EU member states. The MDR requirements — which tightened significantly in 2021 — include technical file documentation, clinical evaluation, and post-market surveillance obligations. We've maintained CE (EU MDR) compliance through the transition and can provide the technical documentation your EU importer of record needs.
If you're importing into the EU for the first time, the MDR 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 needs before you place the order.
ISO 13485:2016
ISO 13485 is the medical device quality management standard. It's not the same as ISO 9001 — it requires documented risk management, design controls, and traceability at a level that most general manufacturers don't maintain. Our ISO 13485 certification covers our full production operation, including this product.
SGS
SGS audit and testing verification provides independent confirmation of our quality system and product performance claims. Test reports are available with your shipment documentation.
Other Target Markets
For buyers supplying Middle East government tenders, Southeast Asian hospital procurement, or African health ministry contracts, we can discuss the specific documentation requirements for your target market. The certification stack above covers the two most demanding regulatory environments (US and EU); other markets typically accept these as baseline compliance evidence.
Discuss Compliance Documentation for Your MarketWhere This Product Sells: Market Segments Worth Targeting
Hospital and Clinical Supply Chains
Hospital systems and healthcare GPOs (Group Purchasing Organizations) buy N95 surgical masks on annual or multi-year contracts, typically in volumes of 500,000 to several million units per contract cycle.
The combined N95 + surgical rating is increasingly specified in hospital procurement standards because it covers both airborne and fluid exposure in a single SKU.
For distributors supplying hospital systems, this product commands a meaningful premium over standard surgical masks and competes in a segment where FDA 510(k) registration is a non-negotiable entry requirement — which filters out most of the commodity competition.
Government and Institutional Tenders
Government health agencies, military medical procurement, and emergency stockpile programs regularly issue tenders for N95 surgical masks with specific certification requirements.
These tenders often specify NIOSH compliance, FDA registration, and ISO 13485 quality system certification — all of which this product carries.
Tender volumes are large (often 1–10 million units per award) and payment terms are typically reliable. If you're building a business around government health procurement, this product's certification stack is the entry ticket.
Private-Label Healthcare Brands
The healthcare PPE private-label market has grown substantially since 2020. Distributors and healthcare brands building their own product lines need a factory that can produce to spec, carry the certifications, and put their brand on the packaging.
We handle OEM packaging in-house — your brand, your box design, your label — without a separate packaging supplier in the chain.
MOQ for standard OEM runs starts at 50,000 pieces.
Occupational Health and Industrial Safety
High-exposure industrial environments — construction with silica dust, pharmaceutical manufacturing, chemical processing — require N95-rated respiratory protection.
The surgical rating adds fluid resistance that some industrial applications also require.
Occupational health distributors serving these sectors can position this product as a premium option over standard N95 respirators, with the surgical certification as a differentiating feature for buyers who want the combined protection.
Production Process: How We Build Consistency Into Every Batch
The N95 surgical mask is a more complex production challenge than a standard 3-ply surgical mask. The cup-shaped or flat-fold geometry requires precise die-cutting and forming. The five-layer construction — including two meltblown layers for the N95 filtration performance — requires tighter layer alignment tolerances than a three-layer product. The head strap attachment points are structural: if the ultrasonic weld fails under tension, the mask fails in use.
Ultrasonic Welding Throughout
Our production lines use ultrasonic welding for nose wire embedding, ear-loop or head-strap attachment, and edge sealing.
Ultrasonic welding eliminates adhesive variability: the bond strength is determined by machine parameters (frequency, amplitude, weld time), not by operator technique.
The 50,000th mask in your order is structurally identical to the first because the weld parameters don't drift the way manual processes do.
In-Process Inspection
In-process inspection runs at defined intervals on each line. Operators check weld integrity, nose wire placement, strap attachment force, and mask dimensions against tolerance specs.
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. It requires discipline to stop a running line. We've built it into the standard operating procedure because the alternative — discovering a batch failure at outgoing inspection — is more expensive for everyone.
Pre-Ship QC Lab Testing
Before any batch ships, our in-house QC lab runs BFE, PFE, and Delta-P testing on a statistically sampled set.
These are the same three performance parameters that determine whether a mask meets ASTM F2100 and NIOSH requirements.
We test in-house first, then submit to third-party labs for the certification documentation that travels with your shipment.
Machine-Controlled Bonding
Frequency, amplitude, weld time — no operator variability
Line-Stop Discipline
Out-of-spec detection halts production immediately
Dual-Layer Verification
In-house lab + third-party certification per batch
OEM and Private-Label Options
Standard OEM work — your brand on our existing N95 surgical mask product — is straightforward. You provide artwork files and packaging specifications; we run a sample approval set before full production. Typical OEM lead time on standard SKUs is 15–25 days from order confirmation, depending on volume and current line scheduling.
Custom Configurations Available
For custom configurations, our engineering team can work with you on:
Packaging Format
Retail-ready individual pouches, clinical bulk packaging, shelf-ready display boxes
Labeling
Private-label printing with your brand, regulatory markings for your target market, barcode and lot number formats
Color
Custom mask body colors on runs that justify the material changeover
Strap Configuration
Head-strap (standard for N95 surgical) or ear-loop configuration for markets where ear-loop is preferred
Fit Geometry
Cup-shaped or flat-fold, depending on your market's preference
MOQ & Lead Time
Standard SKUs: MOQ starts at 50,000 pieces
OEM lead time: 15–25 days from order confirmation
Custom configurations: Higher minimum to justify line setup and material procurement — communicated upfront rather than after sample approval
Packaging, Container Loading, and Landed Cost
Standard Packaging
10 pieces per inner box, 200 pieces per master carton. Carton dimensions are designed for container efficiency — 20GP and 40HQ loading is optimized to minimize wasted cubic space, which directly affects your landed cost per unit.
Standard Pack Configuration
Private-Label Packaging Options
For buyers building private-label programs, we can produce:
Individual Retail Pouches
For pharmacy and consumer health channels
Clinical Bulk Packaging
For hospital and institutional supply
Shelf-Ready Display Packaging
For distributor and wholesale channels
Export Documentation
Prepared with every shipment:
- Certificate of conformity
- BFE/PFE/Delta-P test reports
- Packing list
- Market-specific declarations your customs broker or compliance team needs
Market-Specific Import Support
Choosing Between Our Surgical Mask Products
| Disposable Surgical Medical Mask | N95 Surgical Medical Mask Current Product | 3 Ply Medical Mask | |
|---|---|---|---|
| Filtration | ≥95% BFE | ≥95% PFE + ≥98% BFE | ≥95% BFE |
| Fluid Resistance | ASTM F2100 Level 2 | ≥120 mmHg (Level 2/3) | Standard |
| Regulatory | FDA, CE, ISO 13485 | FDA 510(k), CE MDR, ISO 13485 | CE, ISO 13485 |
| Best for | Standard surgical and clinical use | High-acuity clinical, OR, ICU, government tender | General medical and healthcare settings |
| MOQ | 50,000 pcs | 50,000 pcs | 50,000 pcs |
- Filtration
- ≥95% BFE
- Fluid Resistance
- ASTM F2100 Level 2
- Regulatory
- FDA, CE, ISO 13485
- Best for
- Standard surgical and clinical use
- MOQ
- 50,000 pcs
- Filtration
- ≥95% PFE + ≥98% BFE
- Fluid Resistance
- ≥120 mmHg (Level 2/3)
- Regulatory
- FDA 510(k), CE MDR, ISO 13485
- Best for
- High-acuity clinical, OR, ICU, government tender
- MOQ
- 50,000 pcs
- Filtration
- ≥95% BFE
- Fluid Resistance
- Standard
- Regulatory
- CE, ISO 13485
- Best for
- General medical and healthcare settings
- MOQ
- 50,000 pcs
Which product fits your channel?
If your buyers are in standard clinical or outpatient settings, the Disposable Surgical Medical Mask covers the requirement at a lower unit cost.
If they need the combined N95 + surgical rating — operating rooms, ICUs, government stockpile programs — this product is the right specification.
If you're building a broad healthcare distribution catalog, the 3 Ply Medical Mask fills the general-use tier.
Frequently Asked Questions
What is the difference between an N95 mask and an N95 surgical mask?
A standard N95 respirator meets NIOSH 42 CFR Part 84 requirements for ≥95% filtration of non-oil-based particles. An N95 surgical mask meets that same filtration standard AND the fluid resistance and bacterial filtration requirements for surgical environments (ASTM F2100 or equivalent).
The surgical designation requires additional testing — specifically fluid resistance at ≥120 mmHg and BFE ≥98% — that a standard N95 respirator is not required to pass. For hospital procurement and government health tenders, the surgical designation is often a mandatory specification.
Does this product meet NIOSH requirements for the US market?
Our N95 surgical medical mask is produced to NIOSH 42 CFR Part 84 N95 class specifications and the product is FDA 510(k) registered for the US market. For buyers importing into the US, the FDA 510(k) registration is the relevant clearance for surgical masks sold into healthcare channels.
Contact us for the specific registration number and supporting documentation for your import records.
What is the MOQ, and what are typical lead times?
MOQ for standard SKUs is 50,000 pieces. Lead time on standard configurations runs 15–25 days from order confirmation, depending on order volume and current production scheduling.
We'll give you a specific delivery date — not a range — once we confirm your order details. For OEM/private-label runs, lead time depends on packaging complexity and sample approval timing.
Can you supply test reports for BFE, PFE, and Delta-P?
Yes. Our in-house QC lab runs BFE, PFE, and Delta-P testing on every production batch. Third-party lab test reports are prepared as part of the standard export documentation package and travel with your shipment.
We can provide sample test reports before you place an order — contact us to request them.
What documentation do I need to import this product into the EU under MDR?
EU MDR requires a declaration of conformity, CE technical file, and registration in the EUDAMED database (for the EU importer of record). We provide the declaration of conformity and CE technical file summary with every EU shipment.
If you're setting up EU importation for the first time, we can walk you through what your importer of record will need before you place the order — we've done this with multiple European customers since the MDR transition in 2021.
What customization is available for private-label programs?
Standard OEM: your brand and packaging design on our existing product, with sample approval before full production.
Custom configurations available include:
- Packaging format (retail pouch, clinical bulk, display box)
- Strap type (head strap or ear loop)
- Mask geometry (cup or flat-fold)
- Custom colors on qualifying run sizes
MOQ for standard OEM starts at 50,000 pieces; custom configurations require higher minimums depending on the scope of change.
Get a Quote for This Product
If you're evaluating this product for a specific tender, distribution program, or private-label project, the fastest path forward is a direct conversation. Send us your target market, estimated volume, and any certification requirements specific to your buyers — we'll come back with a detailed quote, relevant test reports, and a sample timeline.
Most new buyers start with a sample order to verify performance against their own testing protocols before committing to full production volumes. We can ship samples within the standard lead time for your review.
Building 3, Zhilan Industrial Park, No. 88 Heng'er Road, Gaomi Economic Development Zone, Gaomi, Weifang, Shandong, 261500, China