Professional Grade Fluid Resistant Surgical Mask Sterile EN14683 Type IIR High Filtration Protection ISO13485 Certified

Product Overview

Engineered specifically for demanding clinical environments, emergency care, and critical contamination control, this medical surgical face mask serves as an uncompromising physical barrier against liquid splash, aerosol transmission, and hazardous bio-particles. Constructed to meet the rigorous European EN14683 Type IIR standards, the mask provides complete coverage over the nose, mouth, and lower jaw, safeguarding medical personnel and individuals from high-pressure fluid impacts and micro-pathogens.

Each lot is manufactured under strict ISO13485 quality control parameters and undergoes Ethylene Oxide (EO) sterilization, ensuring medical-grade sterility directly out of the box for high-hygiene applications.

• 16.0 kPa Fluid & Splash Immunity: Tested under high-velocity fluid projection conditions, the outer fluid-repellent non-woven barrier completely prevents synthetic blood, bodily fluids, and liquid contaminants from penetrating the inner layers.

• Dual-Action Filtration Core: Utilizing high-density melt-blown filtration technology, the middle layer achieves over 95% Bacterial Filtration Efficiency (BFE) and superior Particle Filtration Efficiency (PFE), effectively capturing airborne microbes and particulate matter down to sub-micron scales.

• Zero Moisture-Retention Design: The inner non-woven lining features rapid moisture-wicking properties, absorbing exhaled breath quickly to prevent skin maceration, facial chafing, and air-passage constriction during long surgical procedures.

• Aero-Dynamic Low Resistance: Despite its multi-layered dense structure, the mask maintains a differential pressure below 49 Pa, ensuring smooth airflow and continuous breathing comfort over extended shifts.

• EO Sterilized & Hypoallergenic: Thoroughly processed with Ethylene Oxide to eliminate microbial threats (residual EO maintained below 10mg/kg), using 100% latex-free and skin-neutral materials.

• 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

• EU Conformity Statement: Valid Declaration of Conformity under EU Council Directive 93/42/EEC and Harmonized Standard EN 14683:2019 Type IIR, supported by a designated European Authorized Representative (EC REP in Spain).

• International QMS Standard: Certified by TÜV SÜD for ISO 13485:2016 Medical Device Quality Management Systems, ensuring end-to-end traceability from raw material sourcing to final packaging.

• National Medical Approval: Fully registered as a Class II Medical Device with China NMPA (Registration No. 浙械注准20202141200).