3-ply Non-woven Tie-on Surgical Face Mask EN14683 Type IIR & ASTM F2100 Compliant with Customizable Size
MOQ:
20000 pieces
Delivery Time:
10 to 30 work days
Brand:
Hubei Haixin
Product Description
Bulk Supply 3-ply Non-woven Tie-on Surgical Face Mask EN14683 Type IIR & ASTM F2100 Compliant | ISO13485 Manufacturer
Our 3-ply tie-on surgical masks are engineered for high-risk clinical environments where secure fit and superior filtration are non-negotiable. Unlike earloop masks, the tie-on design ensures a customizable, slip-free fit for extended surgical procedures. As a dedicated PPE manufacturer, we provide stable supply chains and rigorous quality control for global medical distributors.
This tie-on surgical mask can be supplied at ASTM Level 2 or Level 3 (equivalently EN14683 Type II or Type IIR) as per your procurement requirements. The tie-on design is particularly suitable for long-hour surgical wear, avoiding pressure damage caused by elastic ear loops.
Superior 3-Ply Protection
- Outer Layer: Hydrophobic non-woven fabric to block fluid splashes
- Filter Layer: High-density melt-blown fabric (BFE/PFE ≥ 99%) for pathogen capturing
- Inner Layer: Soft, hypoallergenic non-woven fabric for skin comfort
Secure Tie-On Design
Two sets of reinforced non-woven ties allow for precise adjustment, reducing pressure on ears and preventing shifting during movement.
Integrated Nose Wire
Adjustable aluminum or plastic nose bridge ensures a tight seal, minimizing fogging for eyeglass wearers.
Product Specifications
| Material | Non-woven + Meltblown + Non-woven |
| BFE/PFE | ≥ 98% - 99% (Compliant with EN14683 Type II/IIR or ASTM Level 1/2/3) |
| Size | 17.5*9cm |
| Ties Length | 40cm ± 2cm |
| Gram Weight | 20g + 20g + 25g / Customizable |
| Sterilization | Non-sterile or EO Sterile (Optional) |
| Pressure Differential (Breathability) | < 5.0 mm H₂O/cm² |
| Fluid Resistance | 160 mmHg (Type IIR) |
Protection Level Comparison
| Protection Level / Standard | Key Performance Indicators | Scene Description |
|---|---|---|
| ASTM Level 1 / EN14683 Type I | BFE ≥ 95% Pressure difference < 5.0 Resistance to synthetic blood penetration: 80 mmHg |
Suitable for non-invasive operations and without the risk of splashes in daily medical scenarios, suitable for bulk purchasing with limited budgets |
| ASTM Level 2 / EN14683 Type II | BFE ≥ 98% Pressure difference < 6.0 Resistance to synthetic blood penetration 120 mmHg |
This model of mask has a basic performance level; it is suitable for large-scale reserves in regular surgical departments of hospitals and outpatient surgery centers. |
| ASTM Level 3 / EN14683 Type IIR | BFE ≥ 98% Pressure difference < 6.0 Resistance to synthetic blood penetration: 160 mmHg |
Recommended for scenarios where there is a possibility of blood/body fluid splashes or high-concentration aerosols; The strap-on design ensures long-term wearing stability. |
| Industrial / Daily Protection (Non-surgical Use) | No liquid barrier requirement - only filtration of particulate matter is required | Low-cost three-layer non-woven fabric solution; although not suitable for high-risk medical applications, it is suitable for large-scale wholesale of labor protection products. |
Applications
- Hospital routine care
- Blood draws, suturing, catheter insertion
- Labs and testing centers
- Dental clinical environments
Why Partner With Us?
- Certifications: Fully compliant with CE (MDD/MDR), FDA, and ISO 13485 standards
- Manufacturing Scale: Daily capacity of 1 million+ units to ensure prompt delivery for large-scale tenders
- OEM/ODM Service: Custom logo printing, specialized packaging, and private labeling for international brands
- Quality Assurance: Each batch undergoes rigorous testing for differential pressure, fluid resistance, and filtration efficiency
Wholesale & OEM Services
- MOQ: Flexible quantities for initial trial orders
- Customization: Private labeling, custom GSM weights, and specific packaging configurations available
- Supply Capacity: 2,000,000+ units per month with shortened lead times
Contact Us
Request a B2B quotation or sample kit. OEM/private label welcome.
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Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.
Company
Hubei Haixin Protective Products Group Co., Ltd.
Location
Room 916-918, Floor 9, International Finance Center, No.296, Xinhua Road, Wuhan City, Hubei Province, China
Contact Person
Email