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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 K102558
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
Applicant
TANGSHAN HENGDA PLASTIC PRODUCTS CO., LTD
#209 BEI SI HUAN ZHONG ROAD
RM 1606 BLDG 1 JIANXIANG YUAN
HAIDIAN DISTRICT, BEIJING,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
TANGSHAN HENGDA PLASTIC PRODUCTS CO., LTD
#209 BEI SI HUAN ZHONG ROAD
RM 1606 BLDG 1 JIANXIANG YUAN
HAIDIAN DISTRICT, BEIJING,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/07/2010
Decision Date 11/12/2010
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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