Clearance Summary
MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU received FDA 510(k) clearance under submission number K092586, sponsored by Innolatex (Thailand) Limited. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2010-05-12.
- Submission: K092586
- Applicant / Sponsor: Innolatex (Thailand) Limited
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2010-05-12
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.