PRODUCTS

ASTM Level 3 Face Mask, FDA 510(k)

Art No.:

A-31-L3

Material: polypropylene + meltblown + polypropylene

Categotry

FDA Surgical Face Mask

Products

• Compliant with ASTM F2100 Level 3 Standard – Meets the highest level of protection defined by ASTM for medical face masks, suitable for procedures with high risk of fluid exposure

• FDA Listed / Medical Grade – Manufactured in accordance with FDA requirements for medical devices, ensuring safety and quality consistency

• High BFE & PFE ≥ 98% – Provides excellent bacterial filtration efficiency and particle filtration efficiency required for Level 3 masks

• High Fluid Resistance – Designed to resist high-pressure synthetic blood penetration, suitable for surgical and high-risk medical procedures

• 3-Layer High-Performance Structure: Outer layer: Fluid-resistant spunbond nonwoven to repel splashes and droplets, Middle layer: High-efficiency melt-blown filter for bacterial and particle filtration, Inner layer: Soft absorbent nonwoven for moisture control and comfort

• Adjustable Nose Clip – Built-in flexible nose wire helps achieve a secure fit and reduces fogging of glasses

• Latex-Free & Skin-Friendly – Suitable for sensitive skin and long working hours

• Soft Elastic Ear Loops – Comfortable earloop design allows quick wearing and removal while maintaining a stable fit
Relevant Standard

The face mask meet the following standards:

510(k) ASTM Level-3

Primary Applications
- Hospitals and surgical rooms
- High-risk medical procedures
- Emergency and intensive care units
- Dental clinics
- Laboratories and research centers
- Outpatient and healthcare facilities
- Pharmaceutical manufacturing
- Cleanrooms and controlled environments
- Infection control and public health protection
Procurement & Supply Chain Value
- Institutional Sourcing: We manage high-volume procurement and technical fulfillment for complex industrial requirements.
- Total Customization: We execute precise modifications to material weight, dimensions, and packaging to meet rigid client specifications.
- Regulatory Compliance: Our supply chain operates under full international certifications to ensure standardized quality and safety.
- Technical Problem-Solving: We specialize in resolving sourcing bottlenecks and delivering consistent, scalable solutions for large-scale operations.

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DESCRIPTION

Art No. A-31-L3 | 3 layer Polypropylene FDA Level-3 Disposable Surgical Masks

Defender Safety Level Procedural Mask are FDA 510(k)cleared. It is intended to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.

The 3-ply earloop surgical face mask compliant with FDA regulations and ASTM F2100 Level 3 standard is designed for medical and surgical environments requiring the highest level of protection. The mask features a three-layer construction with high bacterial filtration efficiency, excellent particle filtration, and superior fluid resistance, providing reliable protection against splashes, droplets, and airborne particles while maintaining comfort for long-time wear.

Medical grade: FDA 510(k) cleared
Design: Ear loop configuration, pleated mask adjustable nose bridge, blue, not made from natural rubber latex.
Performance: ASTM F2100-19
Dimension: 175mm long, 95mm wide

Art No.: A-31-L3

Material: polypropylene + Meltblown + polypropylene

Model: with round or flat earloop

Colour: blue, green

Packing: 50pcs/box, 40boxes/carton

Carton Size: 52x38x34/2000pcs

FEATURES

• Compliant with ASTM F2100 Level 3 Standard – Meets the highest level of protection defined by ASTM for medical face masks, suitable for procedures with high risk of fluid exposure

• FDA Listed / Medical Grade – Manufactured in accordance with FDA requirements for medical devices, ensuring safety and quality consistency

• High BFE & PFE ≥ 98% – Provides excellent bacterial filtration efficiency and particle filtration efficiency required for Level 3 masks

• High Fluid Resistance – Designed to resist high-pressure synthetic blood penetration, suitable for surgical and high-risk medical procedures

• 3-Layer High-Performance Structure: Outer layer: Fluid-resistant spunbond nonwoven to repel splashes and droplets, Middle layer: High-efficiency melt-blown filter for bacterial and particle filtration, Inner layer: Soft absorbent nonwoven for moisture control and comfort

• Adjustable Nose Clip – Built-in flexible nose wire helps achieve a secure fit and reduces fogging of glasses

• Latex-Free & Skin-Friendly – Suitable for sensitive skin and long working hours

• Soft Elastic Ear Loops – Comfortable earloop design allows quick wearing and removal while maintaining a stable fit

Relevant Standard

The face mask meet the following standards:

510(k) ASTM Level-3

Primary Applications

Hospitals and surgical rooms
High-risk medical procedures
Emergency and intensive care units
Dental clinics
Laboratories and research centers
Outpatient and healthcare facilities
Pharmaceutical manufacturing
Cleanrooms and controlled environments
Infection control and public health protection

Procurement & Supply Chain Value

Institutional Sourcing: We manage high-volume procurement and technical fulfillment for complex industrial requirements.
Total Customization: We execute precise modifications to material weight, dimensions, and packaging to meet rigid client specifications.
Regulatory Compliance: Our supply chain operates under full international certifications to ensure standardized quality and safety.
Technical Problem-Solving: We specialize in resolving sourcing bottlenecks and delivering consistent, scalable solutions for large-scale operations.