Product Overview

Targeted at global healthcare distributors, hospital procurement networks, and industrial safety suppliers, this high-barrier medical surgical face mask delivers clinical-grade infection control and continuous fluid protection. Designed for total facial coverage (covering nose, mouth, and chin), the mask serves as a physical containment barrier against droplet transmission, blood splatter, and environmental bio-aerosols.

Produced under a cleanroom manufacturing framework with Ethylene Oxide (EO) sterilization, this product bridges cost-efficiency with uncompromising safety standards, meeting the stringent EN 14683 Type IIR specifications for global commercial distribution.

• High-Pressure Splash Defense: Engineered with a specialized fluid-repellent outer layer capable of resisting high-velocity liquid and synthetic blood projection up to 16.0 kPa (120 mmHg).
• Multi-Layer Micro-Filtration: High-grade electrostatically charged melt-blown core provides comprehensive particle and bacterial interception, ensuring BFE ≥95% and PFE ≥30%.
• Optimized Airflow Dynamics: Designed to minimize breathing resistance (△p ≤ 49 Pa), enabling healthcare workers and employees to maintain comfort during prolonged duty shifts.
• Skin-Neutral Inner Fabric: Utilizes ultra-smooth non-woven interior lining that actively prevents facial moisture buildup and reduces skin irritation.

• Validated Sterility: EO sterilized with strict residue control (≤10mg/kg), making it fully prepared for sterile clinical and operating room settings.

• Form Factor: Earloop Flat Surgical Mask
• Operational Size: 17.5cm Length × 9.5cm Width
• Component Breakdown:

1. Exterior Barrier: Fluid-resistant PP Spunbond Fabric

2. Core Filter: High-density Electrostatic Melt-blown Layer

3. Interior Layer: Absorbent Soft PP Spunbond Fabric

4. Bridge Fitting: PVC-sheathed Flexible Iron Wire (≥8.0cm)
5. Ear Straps: High-durability Elastic Blend (Polyester & Spandex, Joint Tension ≥10N)

• Safety Standard: Flame retardant construction (Self-extinguishes within 5s)

Packaging, Logistics & Supply Capability

• Packaging Structure: Bulk Sterile Pack (50 pieces per inner box)

• Master Shipper Packing: 2,000 pieces per master carton (40 inner boxes)

• Global Supply Capacity: 500,000+ pieces daily output

• Order Fulfillment: 7 to 15 days turn-around time based on volume
• Contract Manufacturing (OEM/ODM):

1. Customized artwork for inner boxes and outer master shippers
2. Private branding, custom barcoding, and SKU marking
3. Flexible palletization for sea and air freight optimization

• Medical QMS Governance: Certified under ISO 13485:2016 by TÜV SÜD (Certificate No. Q6 003771 0001).
• European Regulatory Access: Official CE Declaration of Conformity under EU Directive 93/42/EEC & EN 14683:2019 Type IIR with an established Spanish EC REP.
• Domestic Medical Registration: Licensed Class II Medical Device by China NMPA (Registration No. 浙械注准20202141200).