DrSharpe Health DrSharpe Health

Surgical Face Mask Manufacturer & Suppliers

Providing OEM/ODM Healthcare Solutions, Globally Certified Grade-3 Protective Medical Masks & End-to-End Global Supply Chain Logistics.

Zhejiang DrSharpe Health Co., Ltd.

Zhejiang DrSharpe Health Co., Ltd. is a professional manufacturer and global supplier specializing in disposable medical and healthcare products, especially high-quality face masks and protective solutions.

With strong manufacturing capabilities, advanced production technology, and strict quality management, DrSharpe is committed to providing safe, reliable, and comfortable healthcare products for customers worldwide.

Manufacturing Capacity & Technology

Our production facilities host 5 fully automatic mask production machines and 12 semi-automatic mask production machines, supported by an experienced production and service team. From raw material selection to final packaging, we strictly control every production process to ensure stable quality and reliable supply. Our products are widely exported to international markets, including the United States, Europe, Japan, Mexico, Germany, and the United Kingdom.

17
Production Lines
>99%
BFE & PFE Rate
20+
Export Countries

Our Quality Standard

Using advanced filtration materials, our masks achieve up to 99% Bacterial Filtration Efficiency (BFE) and 99% Particle Filtration Efficiency (PFE), offering excellent protection and wearing comfort. Our products comply with international standards and have obtained certifications including CE, US FDA, and US EUA.

Global Regulatory Compliance & Standards

Understanding certification requirements is essential for cross-border medical imports. Here is how we meet global parameters.

US FDA 510(k) Registration

We supply surgical masks that adhere to US FDA standards, with registered 510(k) status. Designed in compliance with ASTM F2100 levels, offering fluid resistance, breathability, and synthetic blood penetration protection.

European EN 14683 Type IIR

Designed for maximum splash resistance, our Type IIR surgical masks pass the required EN 14683 evaluations. These feature 120 mmHg fluid resistance and high bacterial filtration (BFE ≥ 99%), making them ideal for surgical and hospital use.

ISO 13485 Quality Management

Our production facilities are certified under the ISO 13485 Quality Management System for Medical Devices. Every batch undergoes strict quality audits from raw material input to final sterilization and container packing.

China's Supply Chain Integration: The DrSharpe Advantage

By operating our facilities in Zhejiang, the heart of China's advanced manufacturing corridor, DrSharpe bridges the gap between raw material supply and global distribution channels.

This geographic location allows us to source premium raw materials—such as high-grade non-woven fabric, meltblown polypropylene, elastic earloops, and malleable nose wires—at unmatched speeds and lower transit costs. The proximity to primary logistics ports like Shanghai and Ningbo guarantees rapid customs transit, loading, and marine logistics dispatch.

Additionally, our 5 fully automatic and 12 semi-automatic lines operate under optimized lean manufacturing procedures. This dual approach allows us to rapidly scale production to fulfill emergency bulk procurement demands while keeping prices competitive for long-term supply agreements.

Supply Chain Control Metrics

  • Direct Access to High-Grade Meltblown: Sourced from trusted chemical manufacturers ensuring consistent BFE/PFE filtration.
  • Proximity to Ningbo/Shanghai Ports: Reduces domestic transit time by 48-72 hours compared to inland facilities.
  • Dual Line Strategy: Dedicated automatic runs for high-volume standard masks, plus flexible semi-auto runs for custom sizes, OEM branding, or children's masks.
  • Standardized ISO Class Cleanrooms: Ensuring low bioburden levels before products enter final inspection.

Strategic Enterprise Procurement & Distribution

We support purchasing departments, healthcare distributors, and industrial supply managers with complex global supply contracts.

Custom OEM & Private Label

We provide full OEM services. This includes custom branding on packaging boxes, diverse strap styles (earloop vs. tie-on), private label master cartons, and custom inner plastic packaging designed for retail and hospital distribution.

Quality Control Reports

Every shipment is backed by laboratory data. We provide BFE/PFE filtration records, differential pressure (breathability) metrics, and fluid splash resistance certifications from independent testing bodies.

Seamless Global Logistics

We support multiple delivery methods, including FOB, CIF, DDU, and DDP. Our logistics department coordinates customs documentation to ensure clear, trouble-free importing into the US, European Union, and Latin American ports.

Applications of Surgical Protective Masks

Designed to deliver reliable respiratory protection and fluid resistance across diverse professional settings.

Clinical & Hospital Settings

Used in operating rooms, emergency wards, and ICU divisions to block pathogens and fluid splashes. High-grade BFE and fluid resistance are vital for surgical staff working in sterile environments.

Dental Clinics & Outpatient Care

Protects practitioners from high-speed aerosol droplets generated during dental procedures. High-breathability features maintain user comfort during long procedures.

Cleanrooms & Electronics Factories

Essential for preventing biological contamination in medical device manufacturing, semiconductor assembly, and pharmacological compounding laboratories.

Future Trends in Medical PPE & Surgical Filtration

The global personal protective equipment (PPE) sector is evolving beyond basic biological barriers. As a prominent surgical face mask manufacturer, Zhejiang DrSharpe Health Co., Ltd. continuously monitors and adapts to these emerging trends:

1. Nanofiber & Electrospun Filtration Layers

Traditional meltblown filters rely heavily on electrostatic charge, which can degrade over time due to humidity and breath condensation. Future filtration technology focuses on sub-micron nanofiber networks. These membranes provide mechanical rather than electrostatic filtration, maintaining reliable protection levels even when wet.

2. Biodegradable & Eco-friendly Materials

Single-use masks generate significant plastic waste. Development is underway for bio-based polypropylene substitutes and biodegradable non-woven fabrics that break down naturally in municipal compost facilities, reducing the environmental footprint of medical disposable materials.

3. Advanced Ergonomics & Skin-Friendly Substrates

Long shifts in clinical settings demand masks that prevent skin irritation and reduce pressure on the ears. Modern developments utilize hypoallergenic, hydro-entangled spunbond inner layers alongside ultra-soft elastic ties to distribute tension evenly, minimizing wearer fatigue.

4. Smart Antimicrobial Treatments

Active filtration utilizing copper, silver, or biological agents is being integrated into outer protective layers. These compounds neutralize pathogens upon contact, reducing risk during mask removal and disposal.

Inside Our Zhejiang Manufacturing Facility

Examine our advanced production lines, testing laboratories, and dust-free packaging setups.

Frequently Asked Questions

Detailed answers addressing regulatory requirements, ordering minimums, and shipping procedures.

What is the difference between ASTM Level 3 and EN 14683 Type IIR surgical face masks?

ASTM Level 3 (typically used in the US) and EN 14683 Type IIR (commonly used in Europe) both represent premium levels of protection, but are tested under different parameters:

  • Fluid Splash Resistance: Both resist fluids at a pressure of 120 mmHg.
  • Bacterial Filtration (BFE): Both demand a threshold of ≥ 98% (Type IIR requires ≥ 99%).
  • Differential Pressure (Delta P): EN 14683 Type IIR requires < 60 Pa/cm², whereas ASTM Level 3 allows < 6.0 mm H₂O/cm².

DrSharpe manufactures models meeting both regional guidelines, backed by testing documentation from accredited third-party laboratories.

Does Zhejiang DrSharpe Health Co., Ltd. offer custom OEM options?

Yes. We offer extensive private-label manufacturing options. We can customize the inner plastic bags, cardboard packaging boxes, master distribution boxes, and mask colors (such as blue, black, white, and customized patterns). Additionally, we provide custom sizes for pediatric use and variations in earloop length and thickness.

How is raw material quality verified before mask assembly?

We source all raw materials from certified domestic suppliers. Every incoming batch of meltblown polypropylene undergoes quality control testing. We measure BFE, PFE, and air permeability. Materials must meet our inner QC threshold (≥ 99% filtration efficiency) before being loaded onto our 17 automatic and semi-automatic assembly lines.

What are your payment terms, minimum order quantities (MOQ), and production lead times?

Our standard terms generally begin with an MOQ of 100,000 units for standard blue 3-ply surgical masks. Payment is typically structured around a T/T deposit, with the balance payable upon presentation of the Bill of Lading (B/L). Production lead times vary depending on size and requirements, but standard orders can typically be packaged and ready for port shipping within 15 to 25 business days.

How do you manage quality control during production?

Our production facilities operate under ISO 13485 quality standards. We conduct regular cleanroom inspections and perform automated optical checks on our machinery. Workers verify physical mask traits—such as nose bridge wire placement and earloop weld strength—before the packaging phase.

All Surgical Face Mask Products