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How to choose Disposable Surgical Mask?(About FDA Standard)

August 11, 2025

Latest company news about How to choose Disposable Surgical Mask?(About FDA Standard)

 

--Introduction

 

The ASTM F2100 Level-3 medical surgical mask is a high-performance disposable face mask designed for use in environments where significant exposure to fluids, aerosols, and infectious agents is expected. Compliant with the American Society for Testing and Materials (ASTM) F2100 standard, this mask provides superior filtration efficiency, breathability, and fluid resistance, making it ideal for surgical and high-risk medical procedures.

 

--Key ASTM F2100 Level-3 Testing Requirements

 

To meet the ASTM F2100 Level-3 classification, the mask undergoes rigorous testing, including:

 1. Bacterial Filtration Efficiency (BFE) – ≥98%

  • Evaluates the mask' s ability to filter out bacteria (e.g., Staphylococcus aureus).
  • Standard: ASTM F2101.  

 2. Particulate Filtration Efficiency (PFE) – ≥98% for 0.1-micron particles​

  • Measures filtration of fine particles, including viruses.
  • Standard: ASTM F2299.

 3. Fluid Resistance – 160 mmHg pressure (high exposure to splashes & sprays)

  • Tests resistance to synthetic blood penetration.
  • Standard: ASTM F1862.

 4. Delta P (Breathability) – <5.0 mm H₂O/cm²

  • Ensures low airflow resistance for comfort during extended wear
  • Standard: MIL-M-36954C/EN 14683.

 5. Flammability (Class 1 Fire Resistance)

  • Confirms the mask material meets safety standards for flame spread.
  • Standard: 16 CFR Part 1610.

 

Advantages of Choosing ASTM F2100 Level-3 Mask

  • Highest Fluid Resistance: Ideal for surgeries and procedures with significant blood or bodily fluid exposure.
  • Superior Filtration: Blocks ≥98% of bacteria and particulate matter, including aerosols.
  • Balanced Comfort: Maintains breathability despite high protection.
  • Trusted Compliance: Meets stringent U.S. regulatory standards for medical masks.

 

Ideal Applications

  • Surgical settings (e.g., operating rooms, dental procedures)
  • High-risk medical environments (emergency rooms, ICUs)
  • Infection control in pandemics or outbreaks

 

Conclusion

 

The ASTM F2100 Level-3 medical surgical mask offers the highest level of protection among standard surgical masks, combining exceptional filtration, fluid resistance, and comfort. Its compliance with rigorous ASTM standards ensures reliability for healthcare professionals and patients in critical settings.

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