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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 K102976
Device Name POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED)
Applicant
Heze Juxinyuan Food Co., Ltd.
Rm.1606 Bld 1 Jian Xiang Yuan
N209 Bei Si Huan Zhong Rd. Hai
Beijing,  CN 100083
Applicant Contact CHU XIAOAN
Correspondent
Heze Juxinyuan Food Co., Ltd.
Rm.1606 Bld 1 Jian Xiang Yuan
N209 Bei Si Huan Zhong Rd. Hai
Beijing,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/06/2010
Decision Date 12/13/2010
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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