4 Ply Disposable Medical Mask
Dual meltblown filtration in a flat-fold disposable — ≥99% BFE without stepping up to an N95.
Built for buyers who need documented high-filtration performance in a standard ear-loop format. Every layer produced in our ISO 8 cleanroom; meltblown fabric made in-house so the filtration spec holds across your entire order.
What the Fourth Layer Actually Does for Your Order
Most disposable medical masks run three layers: spunbond outer, meltblown filtration core, spunbond inner. The 4-ply configuration adds a second meltblown layer — and that's the only change that matters here. Two meltblown layers means two independent filtration stages, which pushes BFE performance from the ≥95% range typical of standard 3-ply masks into ≥99% territory while keeping the flat-fold, ear-loop format your downstream buyers already know how to use.
We don't run this product because it sounds better on a spec sheet. We run it because there's a real market gap between standard 3-ply surgical masks and full N95 respirators — and a lot of buyers need to fill that gap with something that clears customs as a Type II or Type IIR medical mask, not as a respirator. The 4-ply format does that. It gives you documented high-filtration performance with the regulatory footprint of a standard disposable mask, which is a different compliance path, a different price point, and a different end-user experience than an N95.
The practical difference for your buyers
An N95 requires fit testing and user training in most institutional procurement frameworks. A 4-ply disposable mask does not. That distinction matters when you're selling into hospital outpatient departments, dental clinics, or pharmacy chains where compliance overhead is a real procurement barrier.
The four layers in sequence: outer spunbond (fluid resistance, structural shape), first meltblown (primary filtration), second meltblown (secondary filtration), inner spunbond (skin-contact comfort layer). Each layer is sourced or produced in-house and batch-tested before it enters the production line.
4-Layer Construction
Standard 3-Ply
Single meltblown core. ≥95% BFE typical. Standard Type II classification.
4-Ply (This Product)
Dual meltblown layers. ≥99% BFE. Type IIR regulatory footprint. No fit testing required.
N95 Respirator
≥95% PFE at 0.3µm. Requires fit testing, user training, different compliance path.
Technical Specifications
Complete product parameters for procurement evaluation. All values represent industry-standard performance for this product type.
| Parameter | Specification |
|---|---|
| Construction | 4-ply: spunbond / meltblown / meltblown / spunbond |
| Filtration layers | Dual in-house meltblown nonwoven fabric |
| BFE (Bacterial Filtration Efficiency) | ≥99% (typical; tested per EN 14683 / ASTM F2101) |
| PFE (Particulate Filtration Efficiency) | ≥99% (typical; tested per ASTM F2299) |
| Delta-P (Breathability) | ≤40 Pa/cm² (typical) |
| Fluid resistance | ≥120 mmHg (Type IIR equivalent) |
| Nose wire | Dual-ply aluminum, fully embedded via ultrasonic welding |
| Ear loops | Elastic polyurethane, ultrasonic-welded attachment |
| Mask dimensions | Approx. 175 × 95 mm (flat-fold, standard adult size) |
| Outer layer fabric | 25 gsm spunbond polypropylene |
| Inner layer fabric | 25 gsm spunbond polypropylene (skin-contact grade) |
| Meltblown basis weight | 25 gsm per layer (50 gsm total filtration media) |
| Color options | White (standard); custom colors available on request |
| Packaging | 50 pcs/box, 40 boxes/carton (2,000 pcs/carton) — standard |
| Certifications | ISO 13485:2016, CE (EU MDR), FDA 510(k) Registered, ISO 9001:2015, SGS |
Specifications shown are industry-standard values for this product type. Actual specifications may vary by order configuration. Contact us for detailed product data sheets and third-party test reports.
Manufacturing & Quality Assurance
Vertically integrated production with in-house meltblown extrusion ensures consistent filtration performance and full traceability from raw material to finished product.
In-House Meltblown Production
Our own meltblown extrusion lines produce the filtration media used in every mask. No third-party sourcing means consistent quality and supply security regardless of market conditions.
Automated Production Lines
High-speed automated converting lines with ultrasonic welding ensure precise layer alignment, consistent ear loop tension, and repeatable quality at scale.
In-Process Quality Control
Real-time monitoring of meltblown fiber diameter, basis weight, and electrostatic charge. Statistical process control at every production stage.
Batch Testing
Every production batch undergoes BFE, PFE, differential pressure, and fluid resistance testing. Full traceability from raw material lot to finished carton.
Cleanroom Environment
Production in controlled cleanroom conditions (Class 100,000 / ISO 8) with HEPA-filtered air, temperature and humidity control, and gowning protocols.
Scalable Capacity
Multiple parallel production lines support large-volume orders with short lead times. Capacity to fulfill government tenders and multi-facility healthcare contracts.
Certified Quality Management
Our facility operates under ISO 13485:2016 (Medical Devices QMS) and ISO 9001:2015 quality management systems. Products are CE marked under EU MDR, FDA 510(k) registered, and validated by SGS third-party audits.
Use Cases & Applications
Designed for environments where standard 3-ply masks fall short but N95 respirators introduce unnecessary compliance burden.
Hospitals & Clinics
General wards, outpatient departments, and non-aerosol-generating procedure areas. Provides enhanced protection for staff during extended shifts without the discomfort of tight-fitting respirators.
Dental Practices
Fluid-resistant outer layer protects against splatter during procedures. Dual meltblown filtration addresses aerosol concerns from high-speed handpieces.
Laboratories
Sample handling, specimen processing, and cleanroom-adjacent work where particulate filtration matters but fit-tested respirators are not mandated.
Long-Term Care Facilities
Protecting vulnerable populations with enhanced filtration. Easy donning/doffing for staff who change masks frequently throughout shifts.
Pharmaceutical Manufacturing
Product protection in GMP environments. Dual filtration layers reduce operator-shed particulates reaching sensitive production areas.
Travel & Public Health
Airports, public transit authorities, and government stockpile programs seeking above-standard protection without respirator logistics.
Ordering & Logistics
Flexible order quantities with competitive lead times. Direct-from-manufacturer pricing with no intermediary markups.
Standard Packaging
| Inner box | 50 pcs/box |
| Master carton | 40 boxes/carton (2,000 pcs) |
| Carton dimensions | Approx. 60 × 40 × 40 cm |
| Carton weight | Approx. 10–12 kg |
| Shelf life | 3 years from manufacture date |
| Storage | Cool, dry place. Avoid direct sunlight. |
Custom packaging configurations available for orders above MOQ. Private labeling supported.
How to Order
Submit Inquiry
Contact us with your quantity requirements, delivery destination, and any customization needs.
Receive Quotation
We provide pricing, lead time, and shipping options within 24 business hours. Sample orders available.
Production & QC
Order enters production with real-time quality monitoring. Pre-shipment inspection reports provided.
Shipping & Delivery
FOB, CIF, or DDP terms available. Air and sea freight options with full documentation for customs clearance.
Minimum Order Quantity
Standard MOQ: 100,000 pcs (50 cartons). Lower MOQs available for sample and trial orders. Contact us for details.
Why Dual Meltblown Changes the Sourcing Equation
The filtration layer is the one component that determines whether a mask actually performs — and it's the component most mask factories buy from outside suppliers. We produce our meltblown nonwoven fabric in-house. That means we control fiber diameter, basis weight, and electrostatic charge level for both filtration layers in this product.
For a 4-ply mask, in-house meltblown production matters more than it does for a standard 3-ply. Here's why: when you stack two meltblown layers, the interaction between them affects both filtration efficiency and breathability. If the two layers come from different external suppliers — or even from the same supplier across different production runs — the fiber diameter and charge density can vary enough to shift your Delta-P reading outside spec.
We've seen this happen with competitors' products during third-party audit testing. Because we produce both layers ourselves, we tune them as a matched pair. The BFE and Delta-P numbers we quote are the numbers your test lab will confirm.
This also means we can adjust the filtration spec for custom orders. If your target market requires a specific BFE threshold above ≥99%, or a tighter Delta-P for a particular clinical application, we adjust the meltblown parameters rather than sourcing a different fabric. The capability is in-house, not dependent on a supplier's catalog.
Our in-house QC lab runs BFE, PFE, and Delta-P testing on every production batch before outgoing inspection. Third-party test reports from SGS and equivalent labs are available with every shipment — these are the documents your customs broker and compliance team will need for import clearance in the EU and US markets.
Learn About Our Manufacturing Capabilities
Matched-Pair Tuning
Both meltblown layers produced and calibrated together — fiber diameter and charge density optimized as a system, not assembled from separate sources.
Batch-Level QC
BFE, PFE, and Delta-P tested on every production batch. SGS third-party reports included with every shipment for EU and US import clearance.
Custom Filtration Specs
Need a specific BFE threshold or tighter Delta-P for a clinical application? We adjust meltblown parameters in-house — no supplier catalog limitations.
Market Segments Where This Product Earns Margin
Hospital Outpatient & Clinical Settings
500K–Multi-Million Pieces Per ContractOutpatient departments, dental clinics, and diagnostic labs need higher filtration than a standard 3-ply surgical mask but don't require the fit-testing overhead of N95 respirators. The 4-ply format fills that gap precisely.
Hospital procurement teams in Europe and North America increasingly specify Type IIR performance for all clinical-area masks — this product meets that threshold. Institutional tender volumes in this segment typically run 500,000 to several million pieces per contract cycle, with annual renewal patterns that make it a repeatable revenue stream for distributors who get on the approved vendor list.
Pharmacy & Retail Healthcare Chains
Premium SKU — 30–50% Above 3-Ply PricingPharmacy chains in the EU and Gulf states have been moving their house-brand mask programs upmarket since 2021 — standard 3-ply is increasingly positioned as the entry tier, and 4-ply high-filtration is the premium SKU that carries a higher retail price point.
For a distributor building a private-label program, the 4-ply format gives you a product you can legitimately price 30–50% above standard 3-ply while the manufacturing cost differential is narrower than that. The margin structure works.
Government & Institutional Emergency Stockpiles
Large Tender Volumes — Advance Lead TimesProcurement agencies building strategic reserves — national health ministries, regional emergency management bodies, large NGOs — have shifted their specifications toward higher-filtration disposables after the supply disruptions of 2020–2021.
The 4-ply format with CE and FDA documentation clears the compliance requirements for most of these tenders without the respirator classification complexity. Tender volumes are large and lead times are typically negotiated in advance, which suits our production scheduling model.
Industrial & Occupational Health Programs
Step-Up SKU for Elevated Particulate EnvironmentsManufacturing facilities, construction contractors, and logistics operators with occupational health programs often need masks that exceed surgical mask performance without the respirator program requirements. The 4-ply disposable sits in that position.
Occupational health distributors serving these segments can position it as a step-up SKU for environments with elevated particulate exposure — pharmaceutical manufacturing, food processing, electronics assembly — where the extra filtration layer is a defensible specification choice.
This segment has grown significantly for us over the past two years. If you're building a product line for industrial distribution, it's worth including a 4-ply SKU alongside your standard 3-ply offering.
Certifications and Compliance Documentation
The certifications on this product cover the regulatory entry requirements for the markets where high-filtration disposable masks actually move in volume.
CE (EU MDR)
European market access under the Medical Device Regulation. This is the current framework, not the legacy MDD. Our CE documentation is maintained under EU MDR, which means it survives the compliance reviews that have been catching out suppliers who certified under the old directive.
FDA 510(k) Registered
US market clearance for medical devices. Your US customs entry and hospital procurement documentation require this. We provide the 510(k) number and the relevant test reports with every shipment.
ISO 13485:2016
Medical device quality management system. This is the certification that procurement auditors check when they're evaluating a new supplier, not just a product.
ISO 9001:2015
General quality management system certification, providing the foundational quality framework across all manufacturing operations.
SGS Verified
Third-party audit and testing verification. Independent confirmation of manufacturing processes and product performance claims.
For EU Market Buyers
The MDR documentation package includes the technical file, Declaration of Conformity, and notified body involvement where required. We've been through the MDR transition with multiple European customers and can provide the documentation your importer of record needs before you place the order.
EU MDR caught a lot of buyers off guard after 2021 — if you're new to importing medical devices into Europe, ask us about the documentation checklist before you commit to a supplier.
For US Market Buyers
Our FDA 510(k) registration covers the product classification. We provide the 510(k) number and the relevant test reports with every shipment.
Your US customs entry and hospital procurement documentation require this clearance — it's included as standard with every order.
Complete Test Reports Available
All test reports — BFE, PFE, Delta-P, fluid resistance — are available from both our in-house lab and third-party labs. We don't ask you to take our word for the filtration performance.
OEM Packaging and Private-Label Configuration
Standard OEM work on this product is straightforward: your brand artwork on our existing box format, with your product name, lot number format, and any market-specific labeling requirements. We handle the artwork integration and print production in-house.
Sample approval runs before full production — you see the finished packaging before we run your order.
For private-label programs targeting retail pharmacy or institutional supply, we can produce shelf-ready retail boxes (individual consumer-facing packaging) or bulk clinical packaging (500-piece or 1,000-piece inner cartons for hospital dispensing). The packaging format affects carton configuration and container loading efficiency, so it's worth specifying early in the order process.
Customization Options
| Dimension | Options |
|---|---|
| Packaging brand | Your logo, product name, regulatory text |
| Box format | Retail box (50 pcs), bulk clinical carton (500/1,000 pcs) |
| Mask color | White (standard), light blue, pink, custom |
| Ear loop color | White (standard), black, custom |
| Nose wire | Single-ply (standard), dual-ply (standard on this product) |
| Language/labeling | English, French, German, Arabic, others |
| Filtration spec | ≥99% BFE standard; higher thresholds available |
Minimum Order Quantities
Standard OEM (existing product, your packaging): 50,000 pieces.
Custom configurations — modified filtration spec, non-standard mask dimensions, new packaging formats — typically require higher minimums to justify line setup and material procurement. We'll give you the specific MOQ upfront when you describe the configuration.
Packaging Efficiency and Container Loading
Standard Carton Configuration
Standard carton: 2,000 pieces (50 pcs/box × 40 boxes). Carton dimensions are designed for 40HQ container loading without wasted cubic space — this is a detail that affects your landed cost per unit more than most buyers calculate upfront.
Container Loading Capacity
Typical 40HQ loading for this product: approximately 2,400–2,600 cartons, or 4.8–5.2 million pieces per container. 20GP loading runs approximately half that. We'll provide the exact carton dimensions and container loading calculation with your quotation so your freight forwarder can confirm before you commit.
Retail Program Buyers
For buyers building retail programs: retail box packaging (individual 50-piece consumer boxes) ships in the same carton configuration. If you need shelf-ready display packaging or pallet configurations for warehouse receiving, specify that when you inquire — it changes the carton format and we need to account for it in the production run.
Cost Impact Note
Carton dimensions optimized for zero wasted cubic space in 40HQ containers directly reduce your landed cost per unit. We include exact carton dimensions and loading calculations with every quotation so your freight forwarder can verify before you commit to an order.
Packaging Options Available
- Standard export carton (2,000 pcs)
- Retail box packaging (50-piece consumer boxes)
- Shelf-ready display packaging
- Pallet configurations for warehouse receiving
Production Lead Time and Order Process
Standard lead time on this product: 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 and production slot.
First-Time Buyer Process
Inquiry and Spec Confirmation
You send your requirements (volume, packaging spec, destination market, certification needs); we send back a quotation with exact specs and lead time.
Sample Order
Most new buyers request a sample carton (2,000 pieces) before committing to full production; we ship samples within 5–7 business days.
OEM Artwork Approval (If Applicable)
Artwork proof, your approval, then production begins. This step only applies if you're ordering private-label or custom-branded packaging.
Production and QC
In-process inspection throughout; outgoing BFE/PFE/Delta-P testing before shipment. Quality control is integrated at every stage, not just final inspection.
Shipment and Documentation
Full export documentation package with every order. Payment terms and shipping terms are confirmed at the quotation stage. We work with most standard trade terms (FOB Qingdao is typical for our export orders).
What You'll Need for Your Inquiry
-
Order volume (number of pieces)
-
Packaging specification (standard or custom)
-
Destination market
-
Certification needs (CE, FDA, etc.)
We provide exact carton dimensions, container loading calculations, and a specific production date with your quotation — so you can verify everything with your freight forwarder before committing to any order.
Choosing Between 3-Ply and 4-Ply: A Sourcing Decision Guide
Both products sit under our disposable medical mask range. The choice between them is a market positioning decision, not a quality decision — both are manufactured to the same cleanroom and QC standards.
| Factor | 3-Ply Disposable Medical Mask | 4-Ply Disposable Medical Mask |
|---|---|---|
| BFE performance | ≥95% (Type II) | ≥99% (Type IIR equivalent) |
| Fluid resistance | Standard (≥80 mmHg) | Higher (≥120 mmHg) |
| Target market | General clinical, pharmacy, institutional | High-filtration clinical, premium retail, institutional tenders |
| Retail price positioning | Entry to mid-tier | Mid to premium tier |
| MOQ | 50,000 pcs | 50,000 pcs |
| Regulatory classification | Type II medical mask | Type IIR / high-filtration medical mask |
Choose 3-Ply When
Your downstream market is price-sensitive and standard Type II performance is sufficient. The 3-ply disposable medical mask is the right product for general clinical, pharmacy, and institutional distribution where cost-per-unit drives purchasing decisions.
Choose 4-Ply When
You're building a premium SKU, targeting institutional tenders with Type IIR specifications, or positioning against N95 alternatives in clinical settings. The 4-ply is the product that earns the price premium and differentiates your catalog in competitive bids.
Run Both Lines Under One Supplier
A lot of our distributors run a 3-ply standard line and a 4-ply premium line under the same private label. We can produce both from the same factory with consistent packaging formats, which simplifies your supplier management and reduces logistics overhead across your mask portfolio.
Frequently Asked Questions
What is the difference between a 4-ply disposable medical mask and a standard 3-ply surgical mask?
The structural difference is one additional meltblown filtration layer. In practice, this pushes BFE performance from ≥95% (standard Type II) to ≥99%, and typically raises fluid resistance to Type IIR levels (≥120 mmHg splash resistance). The regulatory classification remains a medical mask rather than a respirator, so it doesn't require fit testing or a formal respiratory protection program. For buyers, the 4-ply format occupies the performance tier between standard surgical masks and N95 respirators — higher protection than Type II, lower compliance overhead than a respirator.
Does the 4-ply mask meet EN 14683 Type IIR requirements?
Our 4-ply disposable medical mask is designed and tested to meet EN 14683 Type IIR performance parameters — BFE ≥98% (we typically achieve ≥99%), Delta-P ≤40 Pa/cm², and splash resistance ≥120 mmHg. Our CE certification under EU MDR covers this product. Third-party test reports from SGS are available on request and will confirm the specific test results for your compliance documentation.
What is the minimum order quantity, and can I order a sample first?
MOQ for standard SKUs is 50,000 pieces. For first-time buyers, we ship sample cartons (2,000 pieces) within 5–7 business days so you can test the product with your own customers or submit it for independent lab testing before committing to full production. Sample cost is invoiced at standard unit price; it's credited against your first full order if you proceed.
Can the filtration spec be customized above ≥99% BFE?
Yes. Because we produce our meltblown nonwoven fabric in-house, we can adjust fiber diameter, basis weight, and electrostatic charge parameters to target higher filtration thresholds. If your application requires a specific BFE or PFE above our standard spec — for pharmaceutical cleanroom use, for example, or for a tender with a non-standard filtration requirement — send us the spec and we'll confirm feasibility and the adjusted MOQ for the custom configuration.
What documentation comes with each shipment for EU and US import?
For EU shipments:
CE Declaration of Conformity, technical file summary, EN 14683 test report, and any market-specific labeling compliance documentation your importer of record requires.
For US shipments:
FDA 510(k) registration number, ASTM F2100 test report, and certificate of conformity.
For both markets:
SGS audit documentation, ISO 13485 certificate, packing list, and commercial invoice. If your customs broker or compliance team needs additional documentation, tell us at the order stage — it's easier to prepare it before shipment than to chase it afterward.
How consistent are the specs across multiple orders?
Batch-to-batch consistency is the core reason we brought meltblown production in-house. Every production batch is tested against the same BFE, PFE, and Delta-P parameters in our in-house lab before outgoing inspection. If a batch doesn't meet spec, it doesn't ship — it gets investigated and reprocessed or scrapped. Our ISO 13485 quality management system requires documented traceability for every production lot, so if a question arises about a specific shipment, we can trace it back to the raw material batch. For buyers running private-label programs across multiple order cycles, this is the consistency guarantee that matters.
Get a Quote for This Product
If you know your volume and destination market, send us those details and we'll turn around a quotation with exact specs, lead time, and container loading calculation.
If you're still evaluating whether this product fits your line, request a sample carton first — 2,000 pieces, shipped within a week, so you can test it before you commit.