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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K024324
Device Name LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9
Applicant
Global Protection Corp.
12 Channel St.
Boston,  MA  02210
Applicant Contact DAVIN T WEDEL
Correspondent
Global Protection Corp.
12 Channel St.
Boston,  MA  02210
Correspondent Contact DAVIN T WEDEL
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/26/2002
Decision Date 03/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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