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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K060147
Device Name POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Applicant
Hongye Plastic Products Co., Ltd.
3973 Schafer Ave.
Chino,  CA  91710
Applicant Contact MICKY LIN
Correspondent
Hongye Plastic Products Co., Ltd.
3973 Schafer Ave.
Chino,  CA  91710
Correspondent Contact MICKY LIN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/19/2006
Decision Date 04/28/2006
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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