Clearance Summary
TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR received FDA 510(k) clearance under submission number K904000, sponsored by Armkel, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1991-02-19.
- Submission: K904000
- Applicant / Sponsor: Armkel, LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1991-02-19
Classification & Regulation
This clearance is catalogued under FDA product code HIS and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.