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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 K162312
Device Name Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
Applicant
SHEN WEI USA INC.
33278 CENTRAL AVE
STE 102
UNION CITY,  CA  94587
Applicant Contact CHERYL BAILEY-KROLL
Correspondent
SHEN WEI USA INC.
33278 CENTRAL AVE
STE 102
UNION CITY,  CA  94587
Correspondent Contact CHERYL BAILEY-KROLL
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/18/2016
Decision Date 07/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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