510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K120394Substantially Equivalent

Lifestyles Zero Lubricated Latex Condom

Ansell Heathcare Products, LLC, Dothan AL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120394 is the FDA 510(k) clearance record for LIFESTYLES ZERO LUBRICATED LATEX CONDOM, a class II device, cleared for Ansell Heathcare Products, LLC on under FDA product code HIS (Condom). FDA records list one 510(k) clearance for Ansell Heathcare Products, LLC. As of , FDA records show one recall naming K120394.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ansell Heathcare Products, LLC 1635 Industrial Rd., Dothan AL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIS

Trailing 12 months
3 clearances under product code HIS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIS, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260