3-Ply Medical Surgical Face Mask – Sterile Type IIR Fluid Resistant Protective Mask with ISO 13485 & CE Certification

Product Overview

Our Surgical Medical Face Mask (Sterile Type, Earloop 17.5cm x 9.5cm) is specifically engineered for professional medical settings, healthcare environments, and high-standard commercial protective needs. Designed to cover the user’s mouth, nose, and jaw, it provides a dependable physical barrier against the direct penetration of pathogenic microorganisms, bodily fluids, blood splashes, and airborne particulate matter.

Manufactured in ISO-certified cleanroom environments and fully compliant with international medical standards, this mask balances high filtration performance, fluid resistance, and effortless breathability for long-shift comfort and maximum safety.

• Medical Surgical Grade Protection: Meets stringent medical performance standards, providing high-level physical protection against bacterial transmission and fluid penetration.
• Sterile & Cleanroom Produced: EO (Ethylene Oxide) sterilized to ensure zero bacterial contamination, making it safe for surgical, clinical, and high-hygiene applications.
• 3-Layer High-Efficiency Filtration: 
  1. Outer Layer: Premium hydrophobic non-woven fabric blocks blood, fluid splashes, and large droplets.

  2. Middle Layer: High-density melt-blown filter element ensuring high Bacterial Filtration Efficiency (BFE) and Particle Filtration Efficiency (PFE).

  3. Inner Layer: Hypoallergenic, skin-friendly non-woven lining that absorbs moisture and prevents facial irritation during extended wear.

• Fluid & Blood Splash Resistance: Tested to withstand synthetic blood penetration at 16.0 kPa (120 mmHg) pressure, safeguarding personnel from high-pressure liquid splashes.

• Ergonomic & Comfortable Fit: Equipped with high-elasticity earloops for minimal ear pressure and an adjustable embedded nose wire to achieve an airtight seal without glass fogging.

• Structure & Materials:

1. Outer & Inner Layers: Polypropylene (PP) Spunbond Non-Woven Fabric

2. Filter Layer: Polypropylene (PP) Melt-blown Non-Woven Fabric

3. Nose Clip: Flexible PVC-coated iron wire (length ≥ 8.0 cm)

4. Earloops: High-elasticity Polyester + Spandex straps (Connection tensile force ≥ 10N)

• Sterilization Method: Ethylene Oxide (EO) Sterilization (EO residue ≤ 10mg/kg)
• Key Performance Metrics:

1. Bacterial Filtration Efficiency (BFE): ≥ 95%

2. Particle Filtration Efficiency (PFE): ≥ 30%

3. Synthetic Blood Penetration Resistance: 16.0 kPa (120 mmHg)
4. Differential Pressure (Δp): ≤ 49 Pa
5. Flame Retardancy: Burn time after leaving flame ≤ 5 seconds

• ISO 13485:2016 Certified: Manufactured under a TUV SUD certified Medical Devices Quality Management System (Certificate No. Q6 003771 0001).
• CE Type IIR Compliant: Self-declared conformity under EU Directive 93/42/EEC and Harmonized Standard EN 14683:2019 Type IIR with official EU Representative (EC REP).
• National Medical Device Registration: Officially licensed Class II Medical Device by NMPA China (Registration No. 浙械注准20202141200).
• Comprehensive B2B Support: Full documentation, testing reports, and custom clearance support provided for seamless global importation.