Covid 19 Emergency use Devices and FDA Registration and Listing Information

PPE Kits CE Marking

 

 

#

ProductNatureProduct Code Approval
1Surgical Face MaskSterile / Non-SterileFXX510k
2Face MaskWith Antimicrobial / Antiviral AgentOUK510k
3Face MaskNon-SterileQKRDirect
4N95With Virus / Bacteria filterMSHNIOSH + 510k
5N95Without Virus / Bacteria filterMSHDirect
6Surgical Isolation GownNon-SterileFYC510k
7Isolation GownNon-SterileOEADirect
8Disposable GownNon-SterileFXO

FYE

Direct
9Surgical GownSterileFYA510k
10Head CapNon-SterileFYFDirect
11Latex Examination GlovesNon-SterileLYY510k
12Latex Surgical GlovesSterileKGO510k
13Vinyl Examination GlovesNon-SterileLYZ510k
14Nitrile Examination GlovesNon-SterileLZA

510k

 

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