• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device respirator, n95, for use by the general public in public health medical emergencies
Regulation Description Filtering facepiece respirator for use by the general public in public health medical emergencies.
Definition It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.
Product CodeNZJ
Regulation Number 880.6260
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  GRANTED 1
GLAXOSMITHKLINE
  SUBSTANTIALLY EQUIVALENT 1

-
-