FDA.report

510(k) K232470

Device
Polyisoprene Extra Large Condom
Applicant
Suretex Limited
510(k) number
K232470
Product code
MOL
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-09
Date received
2023-08-16
Regulation
884.5300
Classification name
Condom, Synthetic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Alison Arnot
Address
31/1 Moo 4, Suratthani-Thakuapha Rd. Tambon Khao Kwai, Amphur Phunphin Suratthani TH 84130 84130

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
28859798107035SKYNSURETEX LIMITED - BRANCH2025-07-30
28859798107028SKYNSURETEX LIMITED - BRANCH2025-07-30
28859798107011SKYNSURETEX LIMITED - BRANCH2025-07-30

Other 510(k) Records For Product Code MOL

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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
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