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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 K110185
Device Name NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
Applicant
TANGSHAN BAOJIE GLOVE CO., LTD
ROOM 1606 BLDG1.JIANXIANG YUAN
NO.209 BEI SI HUAN ZHONG RD.
BEIJING,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
TANGSHAN BAOJIE GLOVE CO., LTD
ROOM 1606 BLDG1.JIANXIANG YUAN
NO.209 BEI SI HUAN ZHONG RD.
BEIJING,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/21/2011
Decision Date 04/04/2011
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
Predetermined Change
Control Plan Authorized		 No
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