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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K024121
Device Name NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIM
Applicant
Siam Sempermed Corp., Ltd.
30798 Us Hwy. 19n
Palm Harbor,  FL  34684
Applicant Contact WILLIAM E HARRIS
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NEIL E DEVINE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/16/2002
Decision Date 12/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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