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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 K053523
Device Name POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW)
Applicant
Shijiazhuang Hongxiang Plastics Products Co., Ltd.
3973 Schaefer Ave.,
Chino,  CA  91710
Applicant Contact MICKY LIN
Correspondent
Shijiazhuang Hongxiang Plastics Products Co., Ltd.
3973 Schaefer Ave.,
Chino,  CA  91710
Correspondent Contact MICKY LIN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/19/2005
Decision Date 02/14/2006
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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