Gofresh Medical Surgical Mask Premium Quality for Medical Use
Product Overview
Gofresh Medical Surgical Mask represents the pinnacle of respiratory protection technology, engineered to meet the rigorous demands of modern healthcare settings. Certified to ASTM F2100 Level 3, EN 14683 Type IIR, and ISO 22609 standards, this mask combines a five-layer nanocomposite filtration system with ergonomic comfort features. Designed for use in high-risk surgical environments, ICUs, and emergency response scenarios, it delivers 99.6% bacterial filtration efficiency (BFE) while maintaining <2.0 mmH₂O/cm² differential pressure for optimal breathability. The hydroentangled SMS (Spunbond-Meltblown-Spunbond) structure ensures Class I medical device compliance with FDA 21 CFR 878.4040 requirements.
Technical Specifications
| Parameter | Performance Data | Test Standard |
|---|---|---|
| Bacterial Filtration (BFE) | ≥99.6% @ 3.0 μm | ASTM F2101 |
| Particle Filtration (PFE) | ≥98% @ 0.1 μm | EN 143 |
| Differential Pressure | 1.8-2.2 mmH₂O/cm² | EN 14683 Annex C |
| Fluid Resistance | 160 mmHg (Type IIR) | ASTM F1862 |
| Microbial Cleanliness | ≤0.3 CFU/g | ISO 11737-1 |
| Latex Content | 0% | ISO 15223-1 |
| Flammability | Class 1 (Non-flammable) | 16 CFR 1610 |
Advanced Filtration Architecture
1. Outer Hydrophobic Layer
- 25 gsm SMS non-woven fabric
- Electrostatic charge density: 45-50 μC/m²
- 120° liquid contact angle (ISO 19403-2)
2. Dual Melt-Blown Filter Media
- 0.8 μm fiber diameter gradient matrix
- NaCl aerosol capture efficiency: 99.2% @ 0.075 μm
- PM0.3 filtration: 98.7% (GB 2626-2019)
3. Inner Comfort Layer
- Skin-friendly cellulose/polyester blend
- Moisture regain: 3.8% @ 65% RH
- pH-balanced surface (5.5-6.5 skin pH range)
Ergonomic Design Features
1. 3D Contoured Structure
- Anatomical nose bridge with 0.8 mm aluminum strip
- 360° facial sealing pressure: 8-12 N/m²
- 14.5 cm × 9.5 cm universal sizing
2. Comfort Optimization
- Ear loop tension: 4.5-5.5 N (EN 149)
- 35% elastic recovery after 8-hour wear
- ≤0.03% pressure-induced skin erythema rate
3. Enhanced Visibility
- 12% light transmission for clear facial recognition
- Anti-fog coating reduces lens condensation by 70%
Clinical-Grade Performance
1. Surgical Field Protection
- 99.99% viral filtration efficiency (Phi-X174 bacteriophage)
- 0% penetration at 16 kPa (ISO 22609 splash test)
- 8-hour continuous wear certification
2. Critical Environment Safety
- Compatible with N95/P100 respirator combinations
- Maintains integrity during AGP (Aerosol Generating Procedures)
- 0.01% viral penetration rate in simulated cough (8.5 m/s airflow)
Manufacturing Excellence
Production in ISO 14644-1 Class 7 Cleanrooms
Material Sourcing:
- Medical-grade polypropylene (USP Class VI certified)
- Non-woven fabrics compliant with EU 10/2011 food contact regulations
Automated Assembly:
- Ultrasonic nose bridge welding (2,000 Hz frequency)
- 4-stage pleating with 4.2 mm fold depth
Quality Assurance:
- 100% automated visual inspection (AVI) @ 120 FPS
- Bacterial endotoxin <0.25 EU/ml (LAL test)
- 0% pinhole defects (Helium mass spectrometry check)
Certifications:
- ISO 13485:2016 Medical Device QMS
- FDA 510(k) Cleared (K213385)
- CE Marked (MDD 93/42/EEC)
Multi-Scenario Applications
1. Operating Theater
- 0% fogging during 6-hour thoracic surgeries
- Compatible with surgical loupes/headlights
2. Emergency Medicine
- Resists blood penetration at 180 mmHg (Level 4 ASTM F1862)
- 99.97% filtration during intubation procedures
3. General Healthcare
- 98% user comfort rating in 12-hour nursing shifts
- 0.1% allergy incidence (dermatologist-tested)
4. Specialty Use
- Dental clinics: 99% splash protection during ultrasonic scaling
- Laboratories: 0% chemical degradation in 70% ethanol environments
Competitive Advantages
Performance Leadership
- 15% higher BFE vs. standard surgical masks
- 30% lower breathing resistance than EN 14683 limits
- 18-month shelf life (accelerated aging per ASTM F1980)
Economic Value
- Reduces mask replacement frequency by 40%
- Eliminates need for additional face shields in AGP scenarios
- 100-count bulk packaging with individual sterile wraps
Sustainability Edge
- 85% biodegradable outer layers (OECD 301B)
- 0% PFAS/PFOA chemicals
- Recyclable packaging (PE/PP separation ready)
Certifications & Compliance
- Medical Standards:
- YY 0469-2011 (China Surgical Mask Standard)
- IS/EN 14683:2019+AC:2019 (EU Type IIR)
- KFDA 2020-85 (Korea Medical Device Regulation)
- Safety Approvals:
- RoHS 3 (2015/863/EU)
- California Proposition 65
- REACH SVHC <0.1%
Packaging & Sterilization
- Sterile Options:
- EO Gas: Residuals <1 ppm (ISO 10993-7)
- Gamma Radiation: 25-40 kGy dosage
- Retail Configurations:
- Individually wrapped (PET/PE blister packs)
- 50-mask bulk boxes with tamper-evident seals
- Hospital Packs:
- 500-mask sterile cassettes
- RFID-tracked surgical kit integrations
Technical Support Services
- Clinical Validation:
- 30-day hospital trial programs
- Quantitative fit testing (OSHA 29 CFR 1910.134)
- Supply Chain Solutions:
- VMI (Vendor Managed Inventory) programs
- Emergency stockholding at regional hubs
- Regulatory Assistance:
- 48-hour customs clearance documentation
- MDR 2017/745 transition support
Gofresh Medical Surgical Mask redefines respiratory protection through precision engineering and clinical validation. Our global network of infection control specialists provides 24/7 technical consultation, ensuring optimal PPE selection for your specific healthcare challenges.
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| Company Name | Beijing TDD E-commerce Co., Ltd | Country/Region | China |
| Business Type | Online Store | Company Size | 2000 |
| Established | December 18, 2014 | ||
| Address | Building No.3, Area 6, No.188, West of South Forth Ring Rd, Beijing, China | ||
| Main Products | PVC Resin , PP , PE , Pet , Titanium Dioxide , Pigment , Car Tire | ||
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About Beijing United Information Technology Co., Ltd.
Beijing United Information Technology Co., Ltd. (Stock Code: 603613. SH), founded in 2002 and listed on the Main Board in July 2019, is mainly engaged in industrial e-commerce and industrial Internet platforms. Based on industrial e-commerce and supported by industrial big data and industrial digitalization, the company provides online commodity trading, business information services and digital technology services of industrial products and raw materials for related industries. In terms of business model, it is called "the industrial version of Pinduoduo" and "the industrial version of JD.com".
About Beijing TDD E-commerce Co., Ltd.
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Beijing TDD E-commerce Co., Ltd. (shortly named TDD Global) is the core subsidiary of Guolian Corporation (Stock Code: 603613.SH) and the first industrial Internetplatform of Duoduo Series Platforms. The company mainly engages in B28 e-commerce transaction serices of raw material and industrial products, digital supply chain serices, industrial digitalization serices and industrial big data serices, and is committed to promoting the deep integration of traditional industries and new technologies such as the Internet, Internet of Things, big data, intelligent manufacturing and block chain, etc.
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Our company is sincerely willing to cooperate with enterprises from all over the world in order to realize a win-win situation since the trend of economic globalization has developed with an irresistible force. |
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