DeviceClearance

Product code MOL— Obstetrics/Gynecology

ONE Nitrile Condom

Classification name
Condom, Synthetic
Device class
Class 2
Regulation
21 CFR 884.5300
Advisory panel
Obstetrics/Gynecology
Total cleared
23
First cleared
Most recent

Market context for product code MOL

FDA has cleared 23 devices under product code MOL between 1995 and 2026, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code MOL

Recent clearances under product code MOL

Data sourced from openFDA. This site is unofficial and independent of the FDA.