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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom, Synthetic
510(k) Number K240896
Device Name ONE Nitrile Condom
Applicant
Global Protection Corp.
12 Channel St.
Boston,  MA  02210
Applicant Contact Christina Cataldo
Correspondent
Global Protection Corp.
12 Channel St.
Boston,  MA  02210
Correspondent Contact Christina Cataldo
Regulation Number884.5300
Classification Product Code
MOL  
Date Received04/01/2024
Decision Date 08/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Clinical Trials NCT05912283
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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