Disposable Surgical Medical Mask Factory Direct, Certified for Global Markets
CE (EU MDR) and FDA 510(k) registered disposable surgical medical mask, manufactured in a Class 100,000 cleanroom with in-house meltblown filtration production. Every batch ships with BFE/PFE/Delta-P test reports. Your import documentation is ready before the container leaves our dock.
What This Product Is and Where It Fits in Our Range
The disposable surgical medical mask is our core volume SKU — a 3-ply flat-fold design built to meet ASTM F2100 Level 1/2 and EN 14683 Type IIR performance standards. It is the product most of our distributors and healthcare procurement buyers lead with when entering a new market or building out a private-label program.
Within our surgical medical mask range, this is the broadest-application option. It covers the majority of clinical and institutional use cases — operating rooms, outpatient settings, dental clinics, pharmacy chains, and hospital supply programs — without the added cost of an N95 respirator configuration. If your downstream channel is hospital procurement, government tender fulfillment, or retail healthcare distribution, this is the SKU that moves volume.
The distinction from our other surgical mask configurations: this product runs on our standard 3-ply flat-fold line with ear-loop attachment, optimized for high-volume output and container-efficient packaging. It is not a specialty product — it is a workhorse SKU designed to be sourced at scale, landed at competitive cost, and sold with full regulatory documentation in place.
Key Use Cases
- Operating rooms & surgical suites
- Outpatient & dental clinics
- Pharmacy chains & retail healthcare
- Hospital supply programs
- Government tender fulfillment
Product Positioning
Core volume SKU — broadest application within our surgical mask range.
Technical Specifications
These are the parameters your procurement team will need for comparison sheets and tender submissions. All values are industry-standard for this product type; contact us for the full product data sheet with batch-specific test results.
| Parameter | Specification |
|---|---|
| Construction | 3-ply: spunbond PP outer layer / meltblown filtration layer / spunbond PP inner layer |
| Filtration Layer | In-house produced meltblown nonwoven fabric |
| BFE (Bacterial Filtration Efficiency) | ≥95% (ASTM F2100 Level 1) / ≥98% (Level 2 option) |
| PFE (Particulate Filtration Efficiency) | ≥95% at 0.1 μm |
| Delta-P (Breathability) | ≤5.0 mmH₂O/cm² |
| Fluid Resistance | ≥120 mmHg (Level 2 option) |
| Nose Wire | Dual-ply aluminum, 9 cm, corrosion-resistant |
| Ear Loop | Latex-free elastic, ultrasonic-welded attachment |
| Standard Dimensions | 175 mm × 95 mm (flat-fold, adult size) |
| Weight (per piece) | Approx. 3.5–4.5 g |
| Color Options | White, blue, green, black (standard); custom colors available |
| Packaging | 50 pcs/box, 40 boxes/carton (2,000 pcs/carton) — standard; custom packaging available |
| Shelf Life | 3 years from production date |
| Applicable Standards | ASTM F2100, EN 14683, YY 0469 |
Specifications shown are industry-standard values for this product type. Actual batch specifications may vary. Contact us for detailed product data sheets and batch test reports.
Request a Product Data Sheet≥95% BFE
Bacterial filtration efficiency meeting ASTM F2100 Level 1 standard
≤5.0 mmH₂O/cm²
Low differential pressure for comfortable extended wear
≥120 mmHg
Fluid resistance at Level 2 configuration for splash protection
3-Ply Design
Spunbond PP + in-house meltblown + spunbond PP construction
The Filtration Layer Is Ours — That's the Difference That Matters at Scale
Most mask factories buy meltblown nonwoven fabric from outside suppliers. We produce it ourselves. This is the detail that separates a reliable bulk supplier from one that ships inconsistent product when the supply chain tightens.
Meltblown fabric is the middle layer — the one that determines whether a mask actually hits its BFE spec. The fiber diameter, basis weight, and electrostatic charge level all affect filtration performance, and all three are set during the extrusion process. When you buy from a factory that sources meltblown externally, their BFE consistency is only as good as their supplier's consistency. We've seen what happens when that breaks down: factories shipping masks that test at 85% BFE on a spec sheet that says 95%, because the fabric lot they received was off-spec and they had no way to catch it before production.
We run our own meltblown extrusion line. Every roll of filtration fabric that goes into your order was produced in our facility, tested against our internal spec before it enters the mask production line, and traceable to a specific production batch. When we quote you ≥95% BFE, we know what's in the mask because we made the material.
During periods of meltblown supply disruption — which happen — we don't stop shipping or quietly substitute lower-grade fabric. We control the input.
Our in-house QC lab runs BFE, PFE, and Delta-P testing on every production batch before it reaches outgoing inspection. The test reports that travel with your shipment are generated from actual batch testing, not from a certification file that was issued two years ago. For buyers importing into the EU or US, this matters: your customs broker and compliance team need current test data, not historical certification documents.
In-House QC Testing Per Batch
BFE (Bacterial Filtration Efficiency)
Verified ≥95% on every production batch
PFE (Particle Filtration Efficiency)
Sub-micron particle capture rate tested
Delta-P (Differential Pressure)
Breathability within spec before release
Certifications That Clear Customs in Your Target Markets
Every certification listed below is current and audit-ready. Documentation packages are prepared for your compliance team and customs broker.
ISO 13485:2016
Medical Device QMS
Required for hospital and institutional procurement audits. Demonstrates systematic control of medical device design, production, and post-market processes.
ISO 9001:2015
General Quality Management
Baseline supplier qualification for most procurement programs. Covers process consistency, corrective action, and continuous improvement frameworks.
CE (EU MDR)
European Market Access
Required for import and sale in EU member states. Issued under Medical Device Regulation 2017/745 — the current mandatory framework since May 2021.
FDA 510(k) Registered
US Market Clearance
Required for import and sale in the United States. Your US shipments arrive with regulatory clearance already in place — no separate 510(k) process or US agent needed.
SGS Verified
Third-Party Audit & Testing
Independent verification for buyers who require third-party confirmation of manufacturing processes, material specifications, and test results.
EU MDR Transition — Why This Matters for Your Import
The CE marking on this product is issued under EU MDR (Medical Device Regulation 2017/745), not the older MDD framework. Since MDR became mandatory in May 2021, a significant number of mask suppliers lost their CE status during the transition — either because their technical files didn't meet the new requirements or because their notified body relationships lapsed.
Our CE is current under MDR. If you're importing into the EU for the first time, your importer of record will ask for the Declaration of Conformity and the technical file summary — we have both ready.
FDA 510(k) — Compliance Bottleneck Removed
FDA 510(k) registration means your US shipments arrive with the regulatory clearance already in place. You don't need to manage a separate 510(k) process or work with a US agent to establish clearance — it's done. For distributors building a US healthcare channel, this removes one of the most common compliance bottlenecks at the import stage.
Manufacturing Environment: Class 100,000 Cleanroom, Ultrasonic Welding
Our mask production runs in a Class 100,000 (ISO 8) cleanroom. Particle counts are monitored continuously, and access is controlled.
Facility Standard, Not a Marketing Point
For a product classified as a medical device, this isn't a marketing point — it's the facility standard required to maintain ISO 13485 certification and to pass hospital procurement audits that include facility verification.
Ultrasonic Welding — Eliminating Adhesive Variability
The production lines use ultrasonic welding for nose wire embedding, ear-loop attachment, and edge sealing. Ultrasonic welding eliminates adhesive variability — the bond strength is determined by machine parameters, not operator technique.
The practical result: the ear-loop attachment force on the 500,000th mask in your order is structurally identical to the first.
In-Process Inspection at Defined Intervals
We run in-process inspection at defined intervals on each line, checking weld integrity, nose wire placement, ear-loop 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.
A 500,000-piece surgical mask bulk order doesn't require us to reschedule other customers or run overtime. We give you a delivery date and hold it.
Market Segments Where This SKU Generates Repeatable Volume
Hospital and Clinical Supply Programs
Hospital procurement teams run annual or semi-annual tender cycles for surgical masks, typically in volumes of 500,000 to 5 million pieces per contract.
The documentation requirements are strict — ISO 13485, CE or FDA clearance, batch test reports, and often facility audit rights. This product meets all of those requirements, and we've supplied multiple hospital procurement programs across Europe and the Middle East.
For distributors building a healthcare supply business, this is the segment with the most predictable reorder cadence.
Government and Institutional Tenders
Public health agencies, military medical services, and national stockpile programs issue tenders for certified surgical masks on a regular basis.
These tenders typically specify ASTM F2100 or EN 14683 compliance, require FDA or CE documentation, and demand consistent batch-to-batch performance across multi-shipment contracts.
Our documentation package — certificate of conformity, batch test reports, Declaration of Conformity — is structured to support tender submission requirements directly.
Private-Label Healthcare Brands
Distributors building their own brand in the healthcare consumables space use this product as the base SKU. We handle OEM packaging in-house: your logo, your brand colors, your retail or clinical packaging format.
The mask itself carries the same certifications regardless of what's printed on the box, so your brand launches with full regulatory standing.
This segment has grown significantly for us over the last three years — buyers who started with a single private-label SKU have expanded to full product lines.
Pharmacy and Retail Healthcare Chains
Pharmacy chains and healthcare retailers order in the 100,000–500,000 piece range per SKU per season. They need shelf-ready packaging, consistent product appearance across batches, and clean import documentation.
Our standard packaging is designed for retail shelf display; we can also produce bulk clinical packaging for hospital channel buyers who don't need retail-ready boxes.
Dental and Outpatient Clinic Networks
Dental clinic chains and outpatient networks typically source through a central procurement function, ordering 50,000–200,000 pieces per cycle. The 50,000-piece MOQ on this product fits their volume profile without forcing them to over-commit.
Consistent ear-loop tension and nose wire performance matter in this segment — clinical staff wear these masks for extended periods, and comfort complaints translate directly into procurement complaints.
Volume Ranges by Segment
- Hospitals: 500K–5M pcs/contract
- Government tenders: multi-shipment
- Private-label: scalable from 1 SKU
- Pharmacy/retail: 100K–500K/season
- Dental/outpatient: 50K–200K/cycle
OEM Packaging and Private-Label Configuration
Standard OEM work on this product is straightforward: your artwork files, our packaging spec confirmation, a sample approval run, then full production. We handle printing, box assembly, and labeling in-house — no separate packaging supplier in the chain.
What Can Be Customized
| Element | Options |
|---|---|
| Box design | Full custom print, your brand, any color scheme |
| Packaging format | 10-pc retail pouch, 50-pc clinical box, 500-pc bulk bag, custom configurations |
| Mask color | White, blue, green, black standard; custom colors on runs ≥200,000 pcs |
| Ear loop color | White or black standard; custom on request |
| Language/labeling | Any language; market-specific regulatory labeling (FDA, CE, etc.) included |
| Inner packaging | Individual poly wrap available for premium retail positioning |
MOQ for standard OEM (your brand on our existing product): 50,000 pieces. Custom mask colors or non-standard packaging configurations typically require 200,000 pieces minimum to justify line setup and material procurement — we'll confirm this before you approve samples, not after.
For buyers entering a new market with a private-label program, we can produce a sample run of 500–1,000 pieces for internal review and regulatory pre-submission before committing to full production volume.
Packaging, Container Loading, and Landed Cost
Standard carton: 2,000 pieces (50 pcs/box × 40 boxes). Carton dimensions are designed for 20GP and 40HQ container loading efficiency — we've optimized the carton size to minimize dead space, which directly affects your landed cost per unit.
20GP Container
pieces (standard packaging)
40HQ Container
pieces (standard packaging)
These figures assume standard 50-pc box / 40-box carton configuration. Custom packaging formats will affect loading quantities — we'll provide exact figures when you confirm your packaging spec.
Lead Time
Standard SKUs: 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.
For surgical mask bulk orders above 2 million pieces, we recommend confirming production scheduling 30 days in advance to lock your slot.
Export Documentation
Included with every shipment:
- Certificate of conformity
- Batch BFE/PFE/Delta-P test reports
- Packing list
- Market-specific declarations your customs broker needs
Frequently Asked Questions
What is the minimum order quantity for disposable surgical medical masks?
50,000 pieces for standard SKUs (white or blue, standard packaging). Custom colors or non-standard packaging configurations start at 200,000 pieces. For sample orders prior to full production, we can ship 500–1,000 pieces for product evaluation and regulatory pre-submission.
What is the difference between ASTM F2100 Level 1 and Level 2 for surgical masks?
Level 1 requires ≥95% BFE and fluid resistance of ≥80 mmHg — suitable for low-fluid-exposure clinical environments. Level 2 requires ≥98% BFE and fluid resistance of ≥120 mmHg — the standard for surgical procedures and higher-exposure settings.
Most hospital procurement programs in North America specify Level 2. EU EN 14683 Type IIR is roughly equivalent to ASTM Level 2 in filtration and splash resistance requirements.
We produce both; specify your target standard when requesting a quote.
Does your CE certification cover EU MDR or the older MDD?
EU MDR (Regulation 2017/745), which became mandatory in May 2021. Our technical file and Declaration of Conformity are current under MDR.
If your EU importer of record needs specific documentation for their compliance review, contact us before placing the order — we can provide the full technical file summary.
How do you ensure BFE consistency across large orders?
We produce our own meltblown nonwoven fabric, which is the filtration layer that determines BFE performance. Every roll is batch-tested before entering production.
In-process QC runs at defined intervals on each production line, and outgoing inspection includes BFE/PFE/Delta-P testing on a statistically sampled batch from every production run.
The test reports that ship with your order reflect actual batch performance, not historical certification data.
Can you produce surgical masks with our brand and regulatory labeling for the US market?
Yes. We handle OEM packaging in-house, including FDA-compliant labeling. Since the product carries FDA 510(k) registration, your branded version ships with the regulatory clearance already in place.
We'll confirm the labeling requirements with you during the sample approval stage.
What lead time should I plan for a surgical mask bulk order of 1 million pieces?
15–25 days from order confirmation for standard configurations. For orders above 2 million pieces, we recommend confirming production scheduling 30 days in advance.
We'll give you a specific ship date when we confirm your order — not a range.
Related Products in Our Surgical Mask Range
If this product's specification doesn't match your exact requirements, these alternatives may be a better fit:
N95 Surgical Medical Mask
For markets or procurement programs requiring respirator-level filtration (≥95% PFE at 0.3 μm). Higher per-unit cost, but opens hospital and industrial safety channels that require N95 or equivalent.
View product3 Ply Medical Mask
Standard 3-ply configuration for general medical and non-surgical clinical use. Lower BFE threshold than surgical-grade; suited for markets where ASTM surgical certification is not required.
View productGet a Quote for This Product
Most buyers in this category start with a sample order to verify product performance and run their own BFE testing before committing to full production volume. We can ship samples within 5–7 business days.
If you're ready to discuss volume pricing, tell us your target market, annual volume estimate, and whether you need OEM packaging — we'll come back with a specific quote and a production schedule, not a price list.