FDA approved

ASTM Surgical Masks

Nelson Lab Tested, ASTM Level
Surgical Masks for Healthcare

Taiwan Masks is happy to introduce CSD's line of surgical masks for labs, clinics, and healthcare professionals. These surgical masks conform to the highest specifications for blood penetration, flammability, PFE/BFE, and breathability. 100% FDA registered and approved, the CSD masks have passed all necessary requirements to be used in medical settings.

fda surgical masks

FDA Approved & 510(k) Listed Since 2005

What started out as a special request item is now available and in stock for customers in the health and medical field.

FDA registered and 510(k) listed, this surgical mask is rated ASTM Level 3 by Nelson Labs and is also CE approved. Made in Taiwan by CSD, a company that has been manufacturing medical products for over 70 years.

Nelson Labs Test Results (ASTM 3)

  • Flammability Rating - IBE, 5/5
  • Synthetic Blood Penetration Resistance - None Seen, 31/32
  • Bacterial Filtration Efficiency - Average 99.9%
  • Latex Particle Challenge (PFE) - 98.5 to 99.52%
  • Delta P (mm H20/cm2) - 3.2 to 3.9
  • Delta P (Pa/cm2) - 31.5 to 37.8

For illustration purposes only. Actual product may differ.
Taiwan Masks is an official CSD retailer

csd astm 3 surgical masks

FDA Registration

  • Classification Product Code - FXX
  • Device Classification - Class II Medical Device
  • 510(k) Authorization - K050689
  • FDA Registration Number - 9613778
  • Date Approved - 10/26/2005

Product Test Reports

Click to download

Manufacturer Information

CSD Taiwan
No. 21, Lane 424, Sec. 6, Changnan Road
Changhua City, Changhua
Taiwan 50080

FDA Owner/Operator Number - 9014393

CSD Surgical Masks - USA