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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 K033777
Device Name ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
Applicant
Syntex Healthcare Products Co., Ltd.
P.O. Box 32000
Reno,  NV  89533 -2000
Applicant Contact TITO ALDAPE
Correspondent
Syntex Healthcare Products Co., Ltd.
P.O. Box 32000
Reno,  NV  89533 -2000
Correspondent Contact TITO ALDAPE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/04/2003
Decision Date 02/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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