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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 K082648
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
TANGSHAN DAR PLASTIC & RUBBER PRODUCTS CO. LTD.
RM.1606 BLDG.1 JIANXIANG YUAN
NO.209 BEI SI HUAN ZHONG RD
BEIJING,  CN 10083
Applicant Contact WANG JINCHENG
Correspondent
TANGSHAN DAR PLASTIC & RUBBER PRODUCTS CO. LTD.
RM.1606 BLDG.1 JIANXIANG YUAN
NO.209 BEI SI HUAN ZHONG RD
BEIJING,  CN 10083
Correspondent Contact WANG JINCHENG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/11/2008
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
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