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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name polymer patient examination glove
510(k) Number K223903
Device Name Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)
Applicant
Semperit Investments Asia PTE LTD.
8 Jurong Town Hall Road,
#29-03 To 06 The JTC Summit
Singapore Central,  SG 609434
Applicant Contact Alexander Weinert
Correspondent
Mansour Company LLC
845 Aronson Lake Court
Roswell,  GA  30075
Correspondent Contact Jay Mansour
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received12/28/2022
Decision Date 01/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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