510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K241617Substantially Equivalent

Durex Polyisoprene Condom

Rb Health (Us), LLC, Parsippany NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K241617 is the FDA 510(k) clearance record for Durex Polyisoprene Condom, a class II device, cleared for Rb Health (Us), LLC on under FDA product code MOL (Condom, Synthetic). FDA records list 15 510(k) clearances for Rb Health (Us), LLC, from to . As of , FDA records show no recalls naming K241617.

Clearance record

Decision date
Received
(268 days to decision)
Product code
MOL Condom, Synthetic
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Rb Health (Us), LLC 399 Interpace Pkwy., Parsippany NJ
510(k) summary
Statement
Third party review
No

Clearances, product code MOL

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