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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 K110945
Device Name POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
Applicant
ZHAOYANG PLASTIC CO., LTD
RM 1606 BLDG 1, JIANXIANG YUAN
NO 209 BEI SI HUAN ZHONG RD
HAIDIAN DISTRICT, BEIJING,  CN 100083
Applicant Contact CHU ZIAOAN
Correspondent
ZHAOYANG PLASTIC CO., LTD
RM 1606 BLDG 1, JIANXIANG YUAN
NO 209 BEI SI HUAN ZHONG RD
HAIDIAN DISTRICT, BEIJING,  CN 100083
Correspondent Contact CHU ZIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/04/2011
Decision Date 09/13/2011
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
Predetermined Change
Control Plan Authorized		 No
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