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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 K070008
Device Name POWDERED VINYL PATIENT EXAMINATION GLOVES
Applicant
Zibo Hengde Plastic & Rubber Products Co., Ltd.
# 209 Bei Si Huan Zhong Rd.
Beijing,  CN 10083
Applicant Contact CHU XIAOAN
Correspondent
Zibo Hengde Plastic & Rubber Products Co., Ltd.
# 209 Bei Si Huan Zhong Rd.
Beijing,  CN 10083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received01/03/2007
Decision Date 02/08/2007
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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