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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 K092415
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
SHIJIAZHUANG ELEGANCE PLASTIC PRODUCT
RM 1606 BLDG. 1 JIANXIANG YUAN
NO.209 BEI SI HUAN ZHON RD.
HAIDIAN DISTRICT, BEIJING,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
SHIJIAZHUANG ELEGANCE PLASTIC PRODUCT
RM 1606 BLDG. 1 JIANXIANG YUAN
NO.209 BEI SI HUAN ZHON RD.
HAIDIAN DISTRICT, BEIJING,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/06/2009
Decision Date 09/25/2009
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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