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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 K110146
Device Name NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
Applicant
TANGSHAN KAIYUE GLOVE CO., LTD.
RM 1606 BLDG 1 JIANXIANG YUAN
NO 209, BEI SI HUAN ZHONG RD
HAIDIAN DISTRICT, BEIJING,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
TANGSHAN KAIYUE GLOVE CO., LTD.
RM 1606 BLDG 1 JIANXIANG YUAN
NO 209, BEI SI HUAN ZHONG RD
HAIDIAN DISTRICT, BEIJING,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/18/2011
Decision Date 05/13/2011
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
Recalls CDRH Recalls
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