FDA Product Code MOL: Condom, Synthetic
Leading manufacturers include Global Protection Corp., Suretex Limited and Church & Dwight Co., Inc..
FDA 510(k) Cleared Condom, Synthetic Devices (Product Code MOL)
About Product Code MOL - Regulatory Context
510(k) Submission Activity
22 total 510(k) submissions under product code MOL since 1995, with 22 receiving FDA clearance (average review time: 273 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MOL have taken an average of 191 days to reach a decision - down from 291 days historically, suggesting improved FDA processing for this classification.
MOL devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →