Medical Device Testing

Medical Device Testing

Masks, Gowns, Respirators, and Gloves

Anresco Laboratories now offers medical device testing services to assess the conformity of personal protective equipment (PPE) to required specifications. Services offered include:

  • Face Mask Particulate Filtration Efficiency (PFE) – (ASTM F2100, ASTM F2299)
  • Mask Bacterial Filtration Efficiency (BFE) – (ASTM F2100, ASTM F 2101, EN 14683)
  • Face Mask Air Flow Resistance and Differential Pressure – (ASTM F2100-11, EN 14683)
  • Mask Synthetic Blood Penetration – (ASTM F1862, ASTM F2100, ISO 22609, EN 14683)
  • Face Mask Flame Retardant – (BS EN 136-1998, EN 149, 16 CFR Part 1610)
  • Respiratory Resistance – (ASTM F2100, ASTM F 2299, NIOSH 42CFR84, EN 149, EN 143)
  • Leakage Defect Testing (Medical Gloves and Condoms)
Face Mask

In response to COVID-19, the Food & Drug Administration (FDA) released the following guidance document lifting regulatory requirements for certain masks and respirators to increase their availability. Read more at the following link.

Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency