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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 K103770
Device Name SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
Applicant
Syntex Healthcare Products Co., Ltd.
3973 Schaefer Ave.,
Chino,  CA  91710
Applicant Contact KATHY LIU
Correspondent
Syntex Healthcare Products Co., Ltd.
3973 Schaefer Ave.,
Chino,  CA  91710
Correspondent Contact KATHY LIU
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/27/2010
Decision Date 04/21/2011
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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