510(k) DEN210034

ONE Male Condom by Global Protection Corp. — Product Code QRZ

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: February 23, 2022
Date Received: August 26, 2021
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: External Condom For Anal Intercourse Or Vaginal Intercourse
Device Class: Class II
Regulation Number: 884.5305
Review Panel: OB
Submission Type

An external condom for anal intercourse or vaginal intercourse is a barrier device which covers the penis and is used to prevent the transmission of sexually transmitted infections (when used for anal intercourse or vaginal intercourse) and for contraception (when used for vaginal intercourse). This classification does not include condoms intended for vaginal intercourse only.

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