Covid 19 Emergency use DevicesĀ and FDA Registration and Listing Information

PPE Kits CE Marking

 

 

#

Product Nature Product Code Approval
1 Surgical Face Mask Sterile / Non-Sterile FXX 510k
2 Face Mask With Antimicrobial / Antiviral Agent OUK 510k
3 Face Mask Non-Sterile QKR Direct
4 N95 With Virus / Bacteria filter MSH NIOSH + 510k
5 N95 Without Virus / Bacteria filter MSH Direct
6 Surgical Isolation Gown Non-Sterile FYC 510k
7 Isolation Gown Non-Sterile OEA Direct
8 Disposable Gown Non-Sterile FXO

FYE

Direct
9 Surgical Gown Sterile FYA 510k
10 Head Cap Non-Sterile FYF Direct
11 Latex Examination Gloves Non-Sterile LYY 510k
12 Latex Surgical Gloves Sterile KGO 510k
13 Vinyl Examination Gloves Non-Sterile LYZ 510k
14 Nitrile Examination Gloves Non-Sterile LZA

510k

 

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