What is the FDA 510(K) Surgical Mask?

In response to the ongoing global health challenges, surgical masks have become an essential item for both healthcare professionals and the general public. Among the different types of surgical masks, those that meet the FDA 510(k) Level-3 standard stand out for their superior protection and compliance with rigorous safety regulations. 

Product Standards for FDA 510(k) Level 3 Masks

To be cleared as an FDA 510(k) Level 3 surgical mask, the product must meet stringent requirements under ASTM F2100-21 (or latest version). Key performance criteria include:

1. Bacterial Filtration Efficiency (BFE)

• ≥98%
• Measures how effectively the mask filters out bacterial particles.

2. Particle Filtration Efficiency (PFE) 

• ≥98%
• Tests filtration of submicron particles, such as aerosols.

3. Fluid Resistance

• 160 mmHg
• Indicates protection level against high-pressure fluid splashes, suitable for procedures with high contamination risk.

4. Differential Pressure (OP) / Breathability

• ≤6.0 mm H20/cm²
• Ensures that the mask provides strong protec. Jn without compromising comfort or airflow.

5. Flammability

• Class 1
• Meets flammability requirements for medical environments.

These standards ensure that Level 3 masks deliver maximum protection while maintaining comfort during extended wear.

How To Wear FDA 510(k) Level 3 Masks

1. Wash or sanitize your hands

Before touching the mask, clean your hands thoroughly with soap and water for at least 20 seconds, or use an alcohol-based hand sanitizer.

2. Inspect the mask

Check the mask for any tears, holes, or damage. Do not use a damaged mask.

3. Identify the top and the correct sides

• The top of the mask usually has a bendable metal strip that fits over your nose.
• The colored side (often blue or green) should face outward.
• The white side should touch your face.

4. Position the mask on your face

• Place the mask over your nose and mouth.
• Secure it by:

1. Ear-loop masks: Hook the loops around both ears. 
2. Tie-on masks: Tie the upper strings at the crown of your head and the lower strings at the back of your neck.
3. Headband style: Pull the bands over your head and position them comfortably.

5. Adjust the nose strip

Press and mold the metal strip to the shape of your nose to ensure a snug fit and reduce air leakage.

6. Pull the mask down

Gently pull the bottom of the mask to cover your chin fully. Make sure the mask fits snugly against the sides of your face without large gaps.

7. Avoid touching the mask while wearing it

If you need to touch or adjust it, clean your hands before and after.

8. Removing the mask

• Avoid touching the front of the mask, as it may be contaminated.
• Remove it by handling the ear loops, ties, or bands.
• Dispose of the mask in a closed bin if it is single-use.
• Wash or sanitize your hands immediately after removal.

9. Do not reuse single-use surgical masks

Replace the mask if it becomes wet, damaged, or difficult to breathe through.