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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 K150340
Device Name POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)
Applicant
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD
ESTERN INDUSTRIAL ZONE
NANGONG CITY,  CN 051800
Applicant Contact Shaozhang Nan
Correspondent
Beijing Believe Tech. Service Co., Ltd.
1-202, Build 3, Beijing New World, No.5 Chaoyang Rd.,
Chaoyang District
Beijing,  CN 100024
Correspondent Contact Ray Wang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/11/2015
Decision Date 06/18/2015
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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