Search Results
Found 2 results
510(k) Data Aggregation
K Number
K083176Device Name
PASTURE, MODELS: F550, A520
Manufacturer
PASTURE PHARMA PTE LTD
Date Cleared
2009-01-23
(87 days)
Product Code
NZJ
Regulation Number
880.6260Why did this record match?
Product Code :
NZJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies - Pasture™ A520G Respirator and Pasture™ F550G Respirator
Device Description
Pasture F550G respirator is a duck bill mask as described in NIOSH N95 standard It 1s in 5 layers and composed of spunbond, meltblown and polyester, also with nose cushion, elastic loops and/or strip and nosepiece which is the combination of zinc wires and embedded polyester inside of layers
Pasture A520G respirator is a cone shaped mask as described in NIOSH N95 standard It is in 4 layers and composed of spunbond, meltblown and polyester, also with synthetic rubber band which is coated with polyester and free of latex
Ask a Question
K Number
DEN060009Device Name
3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR
Manufacturer
3M COMPANY
Date Cleared
2007-05-08
(217 days)
Product Code
NZJ
Regulation Number
880.6260Why did this record match?
Product Code :
NZJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1