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Lab Testing

Nelson Labs

Nelson Labs is the leading global provider of laboratory testing and expert advisory services for MedTech and pharmaceutical companies. Specializing in expert advisory and testing solutions for medical device, pharmaceutical, tissue & biologics companies. Website
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PleatMask Test Results:

Number of Test Articles Tested: 32 Number of Test Articles Passed: 32 Per ASTM F1862 and ISO22609, an acceptable quality limit of 4.0% is met for a normal single sampling plan when > 29 of 32 test articles show passing results. Test Pressure: 160 mmhg (21.3kPa)

  • Summary: This procedure was performed to evaluate surgical facemasks and other types of protective clothing materials designed to protect against fluid penetration. The purpose of this procedure is to simulate an arterial spray and evaluate the effectiveness of the test article in protecting the user from possible exposure to blood and other body fluids.
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    Mark Anderson
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    David Schneider
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    David Schneider

100% Pass

All test method acceptance criteria were met. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.