DeviceClearance

Product code ORW— General Hospital

ACTIPROTECT UC N95 RESPIRATOR

Classification name
N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
Device class
Class 2
Regulation
21 CFR 880.6260
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code ORW under 21 CFR 880.6260, via openFDA

Market context for product code ORW

FDA has cleared 1 device under product code ORW, all in 2010, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code ORW

Recent clearances under product code ORW

Data sourced from openFDA. This site is unofficial and independent of the FDA.