medical surgical mask manufacturer: Product Range and Filtration Standards
When sourcing medical surgical mask manufacturer, buyers must understand the distinction between surgical masks and respirators, as well as the filtration standards that apply. Justsun manufactures 3-ply surgical masks at our 26,100mΒ² facility in Xiamen, China, with CE certification and EN 14683 compliance for the European market.
Our surgical mask product line includes the Surgical Mask 3-Ply Blue, a standard medical procedure mask with ear loops for general medical use. The Surgical Mask 3-Ply Green offers the same BFE filtration in a green color preferred in surgical theaters. For buyers seeking white options, the Surgical Mask Earloop White provides a clean, professional appearance for dental and clinical settings.
All models use a three-layer construction: an outer hydrophobic spunbond layer (repels fluids), a middle meltblown filter layer (captures bacteria and particles), and an inner soft skin-friendly layer (absorbs moisture from breath). Key performance metrics include BFE β₯95-99%, PFE β₯95%, differential pressure (breathing resistance) < 40 Pa/cmΒ², and resistance to synthetic blood penetration at 120 mmHg.
Understanding Surgical Mask Standards for medical surgical mask manufacturer
International buyers of medical surgical mask manufacturer encounter multiple standards. Matching the correct standard to your target market is essential:
| Standard | Market | Classification | BFE Requirement |
|---|---|---|---|
| EN 14683:2019+AC:2019 | European Union | Type I / Type II / Type IIR | β₯95% / β₯98% / β₯98% |
| ASTM F2100-19 | United States | Level 1 / Level 2 / Level 3 | β₯95% / β₯98% / β₯98% |
| YY/T 0969-2013 | China (general medical) | General medical mask | β₯95% |
| YY 0469-2011 | China (surgical) | Surgical mask | β₯95% |
Justsun's surgical masks meet EN 14683 Type II (BFE β₯98%) and Type IIR (fluid-resistant, BFE β₯98%) standards. ASTM F2100 Level 2 and Level 3 equivalents are available upon request. Buyers should specify their required standard and classification when requesting a quote.
How to Evaluate medical surgical mask manufacturer Suppliers
Due diligence is critical when sourcing medical surgical mask manufacturer. Follow these verification steps:
- Request CE certificate with EN 14683 classification β Verify the manufacturer name, product model, and notified body on the certificate. Cross-check with the notified body's database.
- Review BFE/PFE test reports β Test results should come from accredited labs (Nelson Labs, SGS, TΓV). Reports must show actual BFE percentage, not just pass/fail.
- Check meltblown fabric source β The filtration layer is the most critical component. Suppliers using in-house meltblown production (like Justsun) offer better quality consistency than those buying from third parties.
- Verify differential pressure β Breathing resistance (ΞP) must be below 40 Pa/cmΒ² for Type I and below 60 Pa/cmΒ² for Type II/IIR. High resistance causes user discomfort and non-compliance.
- Confirm microbial cleanliness β EN 14683 requires β€30 CFU/g for Type I and II. Request microbial test reports for each production batch.
medical surgical mask manufacturer Manufacturing Process at Justsun
The production of medical surgical mask manufacturer at Justsun follows a controlled manufacturing process:
- Meltblown production β The critical filtration layer is produced in-house on dedicated meltblown lines, ensuring consistent electrostatic charge and fiber diameter.
- Three-layer lamination β Spunbond outer layer, meltblown middle layer, and soft inner layer are ultrasonically bonded.
- Cutting and folding β Masks are cut to standard dimensions (17.5cm Γ 9.5cm for adult) with pleats for expandable face coverage.
- Nose clip insertion β Malleable aluminum or plastic nose clips are embedded for secure facial seal.
- Ear loop or tie-on attachment β Ultrasonically welded ear loops or sewn tie-on straps depending on model.
- Individual or bulk packaging β Sterile individual packaging or 50-piece boxes, then master cartons.
- Batch testing β BFE, PFE, differential pressure, flammability, and microbial cleanliness tests on each batch.
Our Quality Control Center operates independently from production, with dedicated BFE and PFE testing equipment. Any batch not meeting EN 14683 parameters is rejected and never shipped.
medical surgical mask manufacturer Pricing and Cost Factors
Several factors influence the pricing of medical surgical mask manufacturer:
- BFE level β Type I (β₯95%) is less expensive than Type II/IIR (β₯98%) due to meltblown quality requirements.
- Fluid resistance β Type IIR with synthetic blood resistance requires additional treatment, adding to cost.
- Order volume β MOQ typically starts at 50,000 pieces; larger orders achieve better per-unit pricing.
- Color β Blue is standard and most economical; green, white, and custom colors may have a small premium.
- Packaging type β Bulk (50/box) is most economical; individual sterile packaging costs more.
- Custom branding β OEM boxes, printed individual wrappers, and private labeling require tooling investment.
Request an itemized quote separating product cost, packaging, certification documentation, and freight.
Packaging, Labeling, and Storage for medical surgical mask manufacturer
Proper packaging and storage maintain the filtration efficiency of medical surgical mask manufacturer:
- Standard packaging: 50 masks per box, 40-60 boxes per master carton. Each box labeled with product name, model, BFE rating, EN 14683 type, lot number, manufacturing date, and CE mark.
- Individual packaging: Each mask sealed in a hygienic pouch for single-use dispensing in clinical settings.
- Sterile packaging: Individually sealed sterile pouches with sterilization indicators for surgical use.
- OEM packaging: Custom-printed boxes and cartons with buyer branding and regulatory labeling.
Storage: Keep in dry conditions at -10Β°C to 40Β°C with relative humidity below 80%. Avoid direct sunlight. Shelf life is 3 years from manufacturing date under proper storage.
Shipping and Export for medical surgical mask manufacturer
Justsun exports medical surgical mask manufacturer globally with full documentation support:
- Sea freight β Most cost-effective for orders over 500,000 masks. Transit: 25-40 days to Europe, 15-25 days to Southeast Asia.
- Air freight β For urgent orders. Transit 5-10 days.
- Express courier β For samples and small orders. Door-to-door in 3-7 days.
Export documentation includes commercial invoice, packing list, certificate of origin, CE/EN 14683 certificates, and bill of lading. Our logistics subsidiary handles customs clearance and freight forwarding.
OEM and Custom Branding for medical surgical mask manufacturer
Justsun offers comprehensive OEM services for medical surgical mask manufacturer:
- Custom box printing β Your brand design, logo, and regulatory information on mask boxes.
- Individual wrapper printing β Branded individual pouches for single-use dispensing.
- Custom colors β Blue, green, white, pink, or custom Pantone colors for the mask outer layer.
- Private labeling β Your company name and contact information on packaging.
- Documentation support β CE certificates and test reports issued under your brand with OEM authorization.
OEM orders typically require 100,000+ pieces minimum. Contact us with your brand requirements for a detailed quotation.
Common Risks When Sourcing medical surgical mask manufacturer
Protect your procurement from these common risks:
Substandard meltblown: Some suppliers use lower-grade meltblown fabric or reduce the meltblown weight to cut costs, resulting in BFE below the claimed level. Always request independent test reports for each shipment.
False certification: Fake CE certificates or EN 14683 certificates are common in the market. Verify certificate numbers and manufacturer names with the issuing notified body.
Color inconsistency: Batch-to-batch color variation may occur with suppliers using different dye suppliers. Specify color tolerance requirements and request pre-production samples.
Packaging damage: Inadequate carton strength during sea freight can crush mask boxes. Confirm carton specifications and pallet packing methods.
Why Choose Justsun as Your medical surgical mask manufacturer Supplier
Justsun has manufactured and exported disposable medical supplies since 1997. Our 26,100mΒ² facility in Xiamen houses dedicated surgical mask production lines, in-house meltblown fabric production, and a Quality Control Center with BFE/PFE testing equipment. With 400+ employees and a vertically integrated supply chain, we deliver EN 14683 certified surgical masks at factory-direct prices.
Our product range includes 3-ply blue surgical masks, green surgical masks, and white earloop masks, all CE certified and available with OEM customization. Contact us for specifications, pricing, and certification documentation.
Frequently Asked Questions About medical surgical mask manufacturer
What is the MOQ for medical surgical mask manufacturer?
MOQ starts at 50,000 pieces for standard models. OEM/custom branding typically requires 100,000+ pieces. Contact us for specific quantity pricing.
What certifications do your surgical masks carry?
Our masks are CE certified under EN 14683:2019 with Type II (BFE β₯98%) and Type IIR (fluid-resistant, BFE β₯98%) classifications. ASTM F2100 Level 2/3 equivalents available. BFE and PFE test reports from accredited labs are provided.
What is the difference between Type I, Type II, and Type IIR?
Type I: BFE β₯95%, for general public use. Type II: BFE β₯98%, for medical professionals. Type IIR: BFE β₯98% with fluid resistance (120 mmHg synthetic blood), for surgical and high-fluid procedures.
What materials are used in your surgical masks?
Three layers: outer hydrophobic spunbond polypropylene, middle meltblown polypropylene filter, inner soft skin-friendly spunbond. Nose clip is malleable aluminum. Ear loops are latex-free elastic.
Can you provide samples before bulk order?
Yes, we provide 10-50 sample masks for quality evaluation. Buyers cover express shipping costs, deductible from the bulk order. Samples ship within 3-5 business days.
What is the lead time for medical surgical mask manufacturer?
Standard production: 15-25 days depending on quantity. OEM: additional 5-10 days for tooling. Shipping: 3-7 days express, 5-10 days air, 15-40 days sea freight.
Do you offer custom colors and branding?
Yes. Standard colors: blue, green, white. Custom colors available for OEM orders (100,000+ pieces). Custom box printing, individual wrapper branding, and private labeling are available.
What are the mask dimensions?
Standard adult size: 17.5cm Γ 9.5cm (earloop) or 17.5cm Γ 9.5cm (tie-on). Child size available: 14.5cm Γ 9cm. Custom dimensions available for OEM orders.
How should masks be stored?
Store in dry conditions at -10Β°C to 40Β°C, relative humidity below 80%, away from direct sunlight. Shelf life is 3 years from manufacturing date under proper storage.
What shipping methods do you support?
Sea freight (FCL/LCL), air freight, and express courier (DHL/FedEx). Full export documentation provided. Our logistics subsidiary handles freight forwarding and customs clearance.