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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 K102593
Device Name SYNTHETIC, POWDER-FREE NITRILE EXAMINATION
Applicant
Zibo Yinghao Medical Products Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Applicant Contact FRANK LIU
Correspondent
Zibo Yinghao Medical Products Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Correspondent Contact FRANK LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/09/2010
Decision Date 12/20/2010
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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