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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 K091429
Device Name VINYL POWDER FREE EXAMINATION GLOVE
Applicant
SHUN DA (XINGHUA) CO., LTD
LOT20, TIAN SHUI HUA TING YUAN
XIANGHUA CITY
JIANGSU,  CN 225700
Applicant Contact ZHANG YAN
Correspondent
SHUN DA (XINGHUA) CO., LTD
LOT20, TIAN SHUI HUA TING YUAN
XIANGHUA CITY
JIANGSU,  CN 225700
Correspondent Contact ZHANG YAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received05/13/2009
Decision Date 07/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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