DeviceClearance

Product code LTZ— Obstetrics/Gynecology

SPERMICIDAL LUBRICATED MALE LATEX CONDOM

Classification name
Condom With Nonoxynol-9
Device class
Class 2
Regulation
21 CFR 884.5310
Advisory panel
Obstetrics/Gynecology
Total cleared
22
First cleared
Most recent

Market context for product code LTZ

FDA has cleared 22 devices under product code LTZ between 1990 and 2004, filed by 17 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

Top applicants under product code LTZ

Recent clearances under product code LTZ

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