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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 K092820
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Applicant
Shijiazhuang Fuhao Plastic Products Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Applicant Contact JOHN ZHAO
Correspondent
Shijiazhuang Fuhao Plastic Products Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Correspondent Contact JOHN ZHAO
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/14/2009
Decision Date 12/03/2009
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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