FDA Product Code ONT: N95 Respirator With Antimicrobial/antiviral Agent
A Single Use, Disposable, Niosh-approved Respirator Intended For Occupational Use 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.
Leading manufacturers include Nexera Medical, Inc., Glaxosmithkline Consumer Healthcare and Filligent Limited.
6
Total
6
Cleared
325d
Avg days
2009
Since
FDA 510(k) Cleared N95 Respirator With Antimicrobial/antiviral Agent Devices (Product Code ONT)
6 devices
Cleared
Dec 29, 2015
SpectraShield 9500 Surgical N95 Respirator
Nexera Medical, Inc.
General Hospital
284d
Cleared
Mar 18, 2013
BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
Filligent Limited
General Hospital
195d
Cleared
Jul 05, 2012
SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR
Nexera Medical, Inc.
General Hospital
160d
Cleared
Feb 24, 2011
SPECTRASHIELD 9500 SURGICAL MASK
Nexera Medical, Inc.
General Hospital
736d
Cleared
May 10, 2010
ACTIPROTECT UF N95 RESPIRATOR
Glaxosmithkline Consumer Healthcare
General Hospital
216d
Cleared
Jul 01, 2009
ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD
Glaxosmithkline Consumer Healthcare
General Hospital
359d