ORW · Class II · 21 CFR 880.6260

FDA Product Code ORW: N95 Respirator With Antimicrobial/antiviral Agent For Use By The General Public In Public Health Medical Emergencies

A Single Use, Disposable, Niosh-approved N95 Respirator Intended For Use By The General Public In Public Health Medical Emergencies To Cover The Nose And Mouth Of The Wearer To Help Reduce Wearer Exposure To Pathogenic Biological Particulates And Has An Added Antimicrobial And/or Antiviral Agent Which Kills Specified Pathogens Under Specified Contact Conditions.

1
Total
1
Cleared
266d
Avg days
2010
Since

FDA 510(k) Cleared N95 Respirator With Antimicrobial/antiviral Agent For Use By The General Public In Public Health Medical Emergencies Devices (Product Code ORW)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code ORW - Regulatory Context