KN95 Masks

Item: KN95 Masks #CUSTOM-KN95
Size (CM): 15.5 x 10.5CM / 4 Layers
Material Specs: PP Non-Woven, Melt-Blown, Soft Cotton, PP Non-Woven
Filtration Level: CE FFP2/KN95

Minimum Order: 1,500 pieces
Must order full case quantities

 

Category:

Description

CERTIFICATIONS

  • The manufacturer, that is a trusted Proforma partner, applied for the extra emergency use authorization.  This can be verified online at FDA.  The FDA gave them verbal approval (because the facility is FDA and CE certified) to move forward with all of their registered products.
  • Letter from FDA confirms emergency use – https://www.fda.gov/media/135763/download
  • FDA enforcement and legal scope of masks for emergency use – https://www.fda.gov/media/136449/download
  • US Customs provides code at entry confirming emergency use and shows they have knowledge masks are coming into the U.S. (non NIOSH)

(Click to view, right-click and select “Save link as…” to download)

FDA Certificate (2)
CE EN149:2001 (1)
CE EN149:2001 (2)
CSMS #42124872 (1)
CSMS #42124872 (2)
Approved EUA FAQ
CNAS KN95 Test (1)
CNAS KN95 Test (2)
ISO
License
Product License of Medical Products
CDC Declaration
Information for Filing PPE (1)
Information for Filing PPE (2)
FDA Registration (1)
FDA Registration (2)

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