Select premium protective masks manufactured under strict medical quality systems, featuring advanced meltblown filtration cores.
As a premier medical mask factory, we ensure our manufacturing protocols strictly align with international standards, delivering certified barrier properties.
In medical and healthcare settings, the ASTM F2100 specification is the North American benchmark for surgical masks. It categorizes masks into three performance tiers based on crucial testing criteria, including Fluid Resistance (splash protection), Bacterial Filtration Efficiency (BFE), Particulate Filtration Efficiency (PFE), Differential Pressure (breathability), and Flammability. Designing high-compliance PPE requires a deep technical understanding of these distinct levels:
| Evaluation Parameter | ASTM F2100 Level 1 (Low Barrier) | ASTM F2100 Level 2 (Moderate Barrier) | ASTM F2100 Level 3 (High Barrier) |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥ 95% (at 3.0 microns) | ≥ 98% (at 3.0 microns) | ≥ 98% (at 3.0 microns) |
| Particulate Filtration Efficiency (PFE) | ≥ 95% (at 0.1 microns) | ≥ 98% (at 0.1 microns) | ≥ 98% (at 0.1 microns) |
| Fluid Resistance (Synthetic Blood Spatter) | 80 mmHg | 120 mmHg | 160 mmHg |
| Differential Pressure (Delta P / Breathability) | < 5.0 mm H₂O/cm² | < 6.0 mm H₂O/cm² | < 6.0 mm H₂O/cm² |
| Flame Spread (Flammability Class) | Class 1 (Pass) | Class 1 (Pass) | Class 1 (Pass) |
ASTM Level 3 masks offer the highest level of splash protection at 160 mmHg, safeguarding surgical staff from arterial blood bursts and high-velocity bodily fluid sprays during complex operations.
Using advanced inline corona charging systems, our factory enhances the particulate filtration efficiency (PFE) of our meltblown nonwoven layer to over 99%, capturing sub-micron viral and bacterial particulates.
By balancing fiber density and structural porosity, we achieve low differential pressure (Delta P < 4.0 mm H₂O/cm² for Level 1, and < 5.0 for Level 3) to prevent fatigue during prolonged surgical wear.
A premier integrated medical tech enterprise driving global healthcare safety through high-efficiency manufacturing.
Henan Tobe Health Co., Ltd. is a comprehensive medical and health technology enterprise, affiliated with a well-established industrial group. The company integrates research and development, manufacturing, sales, and after-sales service, focusing on protective products, medical devices, medical consumables, and health-related equipment.
The company covers an area of approximately 100 mu, with modern production workshops exceeding 400,000 square meters and a workforce of over 3,000 employees. Its business scope spans multiple sectors including healthcare, medical aesthetics, rehabilitation, and health management services, demonstrating strong industrial integration capabilities.
Underpinning our product safety with state-of-the-art laboratory testing and cleanroom automation.
Henan Tobe Health Co., Ltd. has established an advanced R&D center staffed with over 20 experienced engineers and technical experts. The team is dedicated to continuous innovation, product upgrades, and the development of new medical technologies. We leverage precision testing systems to evaluate air resistance, synthetic blood penetration, and bacterial barrier performance for every production batch.
The company utilizes state-of-the-art production lines and precision testing equipment, combined with internationally advanced manufacturing management systems. With more than 20 automated mask production lines and diversified equipment manufacturing capabilities, the company ensures stable supply capacity and consistent product quality.
Our raw polypropylene goes through precise thermal-mechanical meltblown processes, followed immediately by water-electret or corona-charging processing, creating a high-density electrostatic web to trap micro-particulates effectively.
Using premium ES (Ethylene-Propylene Side-by-Side) thermal bond fibers or high-comfort spunbond nonwovens, our mask inner layers are hypoallergenic, preventing skin irritation during long clinical procedures.
We implement fully automated ultrasonic welding systems to fuse the 3-ply structures and ear loops. This ensures a consistent, high tensile strength bond (>10N structural tension limit) preventing strap failure.
Strategic insights into the global medical mask market and next-generation PPE technology.
The global medical mask supply chain has evolved significantly, shifting towards strict regulatory compliance, environmental sustainability, and localized safety configurations. B2B procurement managers now seek certified factories that can withstand macroeconomic pressures, assure transparent manufacturing origins, and supply verified ASTM-compliant products.
At Henan Tobe Health Co., Ltd., we are actively investing in the following technological horizons to maintain our competitive edge as a leading medical device supplier:
Developing PLA (Polylactic Acid) based nonwoven fibers to construct eco-friendly surgical masks, minimizing medical waste burden in oceans and landfills without compromising clinical protection parameters.
Upgrading meltblown membranes to electrospun nanofibers with diameters below 100nm. This creates physical sieving structures that exhibit less structural degradation over time compared to electrostatic charges.
Engineered nose bridge memory-wire configurations coupled with open cell polyurethane foam strips, specifically targeted at healthcare professionals wearing protective eyewear in high-humidity operating theaters.
We strictly adhere to international quality standards, ensuring our products comply with international medical regulations.
The company strictly adheres to international and domestic quality standards. Our products have obtained multiple authoritative certifications, guaranteeing clinical validity and custom clearance optimization for global buyers:
Our medical protective products hold EU CE Certification, US FDA Registration, and EUA (Emergency Use Authorization), enabling frictionless import procedures into North America and the European Economic Area.
Fully compliant with China National Standards: GB2626-2006, GB/T32610. Our production workshops operate in alignment with ISO9001, ISO14001, and ISO45001 management protocols.
Henan Tobe Health Co., Ltd. is listed on the official PPE export whitelist of the Ministry of Commerce of China, validating compliance with global customs regulations and ensuring smooth border clearance.
Connecting high-capacity factories with healthcare facilities, distribution networks, and industrial cleanrooms worldwide.
Since 2020, the company has actively expanded into the global market. Our medical protective masks, surgical drapes, and clinical consumables have been exported to more than 30 countries and regions, including the United States, Canada, the United Kingdom, Italy, France, Spain, Japan, India, and countries across the Middle East, Africa, and South America.
Supported by a professional international sales and service team, Henan Tobe Health Co., Ltd. provides comprehensive procurement assistance, featuring:
Henan Tobe Health Co., Ltd. remains committed to building long-term partnerships with global clients through professionalism, quality, and trust. Our customer-oriented and innovation-driven philosophy guides our focus on improving medical technology and adding value to our global service network.
Explore our technical medical respirator line and certified ASTM-level mask variants for B2B procurement.
Technical answers to help buyers evaluate product performance and quality assurance standards.
The main differences lie in fluid resistance and particle filtration efficiency (PFE/BFE). Level 1 masks are designed for low-fluid environments (e.g., standard examinations, dental checks) with fluid resistance at 80 mmHg. Level 2 (moderate barrier) and Level 3 (high barrier) require higher fluid resistance at 120 mmHg and 160 mmHg respectively, making Level 3 optimal for surgery and high-splash risk environments. Both Level 2 and Level 3 must meet a minimum filtration efficiency of ≥98%.
We operate in alignment with the ISO9001 and ISO13485 quality management systems. Our factory has an advanced R&D center with over 20 engineers. We use raw materials tested for thickness, density, and charge retention, and perform regular automated inspections on our production lines to test BFE, PFE, and differential pressure (Delta P) for every batch.
Yes. Henan Tobe Health Co., Ltd. is listed on the official PPE and Medical Device Export Whitelist of the Ministry of Commerce of China. This guarantees that our production processes, raw materials, and certifications (such as EU CE and US FDA) are verified, helping to prevent customs clearance issues at import borders.
We support customization across several parameters, including dimensions (adult and child sizes), tie-back or elastic earloop attachments, custom branding on mask surfaces, custom packaging (such as sterile individual pouches or bulk boxes), and different material options (including anti-fog foam strips and activated carbon layers for industrial applications).
The shelf life of our medical masks is typically 3 years from the date of manufacture. To maintain the electrostatic charge of the meltblown layer, we recommend storing the masks in their original, sealed packaging in a cool, dry, and well-ventilated space (humidity <80%, temperature between -20°C and +38°C), away from direct sunlight, chemical vapors, or corrosive gases.
Tobe Health
