FDA.report

510(k) K252158

Device
Sagami Original 002 Polyurethane Male Condom
Applicant
Mayer Laboratories
510(k) number
K252158
Product code
MOL
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-30
Date received
2025-07-09
Regulation
884.5300
Classification name
Condom, Synthetic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
David Mayer
Address
1400 Shattuck Ave. Suite 9 Berkeley CA US 94709 94709

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MOL

510(k)DeviceApplicantDecision date
K243967ONE Nitrile CondomGlobal Protection Corp.2025-04-08
K241617Durex Polyisoprene CondomRb Health (Us), LLC2025-02-28
K240379TROJAN SIS Synthetic Latex Condom with Silicone LubricantChurch & Dwight Co., Inc.2024-10-08
K240896ONE Nitrile CondomGlobal Protection Corp.2024-08-23
K232470Polyisoprene Extra Large CondomSuretex Limited2024-05-09
K23190845 Micron Polyisoprene CondomSuretex Limited2023-10-27
K203541Okamoto 002 Lubricated Polyurethane Male CondomOkamoto USA, Inc.2022-02-25
K182438Synthetic Polyisoprene Lubricated Male Condom - 5 sensesSxwell USA, LLC2018-12-06
K171172Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell Healthcare Products, LLC2017-08-02
K171639Trojan Supra Lubricated Polyurethane Male CondomChurch & Dwight Co., Inc.2017-08-01
K160399Skyn Original Polyisoprene Lubricated Male CondomAnsell Healthcare Products, LLC2016-07-25
K100767TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOMChurch & Dwight Co., Inc.2011-04-05
K072169DUREX SYNTHETIC POLYISOPRENE MALE CONDOMSsl Americas, Inc.2008-06-19
K070800LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOMAnsell Healthcare Products, LLC2008-03-06
K050828TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOMChurch & Dwight Co., Inc.2006-02-28