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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K173766
Device Name PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs
Applicant
Shen Wei USA, Inc.
33278 Central Ave.
Suite 102
Union City,  CA  94587
Applicant Contact Cheryl Reep
Correspondent
Shen Wei USA, Inc.
33278 Central Ave.
Suite 102
Union City,  CA  94587
Correspondent Contact Cheryl Reep
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Code
LZA  
Date Received12/11/2017
Decision Date 07/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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