510(k) K093189

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

July 2, 2010

Date Received

October 9, 2009

Clearance Type

Abbreviated

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies

Device Class

Class II

Regulation Number

880.6260

Review Panel

HO

Submission Type

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.