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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 K073193
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
Shijiazhuang Prosperous Plastic Co., Ltd.
Rm.1606 Bldg. 1, Jianxiang Yuan
No 209 Bei Si Huan Zhong Roa
Beijing,  CN 10083
Applicant Contact CHU XIAOAN
Correspondent
Shijiazhuang Prosperous Plastic Co., Ltd.
Rm.1606 Bldg. 1, Jianxiang Yuan
No 209 Bei Si Huan Zhong Roa
Beijing,  CN 10083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received11/13/2007
Decision Date 12/20/2007
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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