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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name vinyl patient examination glove
510(k) Number K160675
Device Name Powder free vinyl patient examination glove, colored (yellow)
Applicant
KAIXING PLASTIC PRODUCTS CO., LITD.
1101 TANGGANG RD LUANNAN COUNTY
Tangshan,  CN
Applicant Contact Dan ny
Correspondent
LICHEN COMMERCIAL INFORMATION CONSULTING CO.,LTD
ROOM 1304, BUILDING 8, YUNTAI RD. 453 PUDONG NEW DISTRICT,
SHANGHAI,  CN 200126
Correspondent Contact Daniel Qiu
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/10/2016
Decision Date 08/02/2016
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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