|Why we have the only FDA-Cleared Viral Barrier
- We have the ONLY ultrasound probe covers FDA-Cleared to be labeled as “viral barriers”*
- We are the ONLY company to test the full length of our probe cover during viral barrier testing! Other tests use a only small piece of material—not the whole product!—which may not include seams or other potentially weak areas.
- Sheathing Technologies products have a LOWER AVERAGE defect rate (< 0.4 %) than our competitors, which have been tested in independent studies as having an average leakage rate varying from 2.3% to 65%.
- Our first-in-class Viral Barrier product EXCEEDS even the barrier standards for condoms
*In vitro testing shows that the probe cover provides a viral barrier from viruses 20 nm in diameter or larger while the probe cover remains intact without leakage.
To view or download the Acrobat PDF version of our Certificates, click on a thumbnail image.