Clearance Summary
ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS received FDA 510(k) clearance under submission number K981621, sponsored by Suretex Prophylactics (India) , Ltd.. 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 1998-06-19.
- Submission: K981621
- Applicant / Sponsor: Suretex Prophylactics (India) , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5310
- Decision date: 1998-06-19
Classification & Regulation
This clearance is catalogued under FDA product code LTZ and 21 CFR 884.5310, within the Obstetrics/Gynecology review panel as a Class II device.