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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 K110621
Device Name SHENGKUN CHEMICAL
Applicant
Zibo Shengkun Chemical Industrial Co., Ltd.
Fine Chemical Park, Chemical
Industry Park Zibo, Shandong
Zibo, Shandong,  CN 255400
Applicant Contact JASON LIU
Correspondent
Zibo Shengkun Chemical Industrial Co., Ltd.
Fine Chemical Park, Chemical
Industry Park Zibo, Shandong
Zibo, Shandong,  CN 255400
Correspondent Contact JASON LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/03/2011
Decision Date 08/24/2011
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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