meddevicedb.com FDA Device Reference

ONE Male Condom

DEN210034 Class II Direct
Decision Date
2022-02-23
Sponsor / Applicant
Global Protection Corp.

Technical Specification

510(k) Submission ID DEN210034
Product Code QRZ
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.5305
Decision Date 2022-02-23
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

ONE Male Condom received FDA 510(k) clearance under submission number DEN210034, sponsored by Global Protection Corp.. The device was reviewed via the Direct premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2022-02-23.

Classification & Regulation

This clearance is catalogued under FDA product code QRZ and 21 CFR 884.5305, within the Obstetrics/Gynecology review panel as a Class II device.