Atlas FDA

MOL

23 FDA 510(k) clearances · Product code

264 daysmedian time to decision
449 days90th percentile
23clearances measured

FDA profile

Official device name
Condom, Synthetic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5300
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
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RecordFirmDate
Sagami Original 002 Polyurethane Male Condom (K252158)Mayer Laboratories2026-03-30
ONE Nitrile Condom (K243967)Global Protection Corp.2025-04-08
Durex Polyisoprene Condom (K241617)Rb Health (Us), LLC2025-02-28
TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (K240379)Church & Dwight Co., Inc.2024-10-08
ONE Nitrile Condom (K240896)Global Protection Corp.2024-08-23
Polyisoprene Extra Large Condom (K232470)Suretex Limited2024-05-09
45 Micron Polyisoprene Condom (K231908)Suretex Limited2023-10-27
Okamoto 002 Lubricated Polyurethane Male Condom (K203541)Okamoto USA, Inc.2022-02-25
Synthetic Polyisoprene Lubricated Male Condom - 5 senses (K182438)Sxwell USA, LLC2018-12-06
Skyn Original Polyisoprene Lubricated Male Condom - Flavored (K171172)Ansell Healthcare Products, LLC2017-08-02
Trojan Supra Lubricated Polyurethane Male Condom (K171639)Church & Dwight Co., Inc.2017-08-01
Skyn Original Polyisoprene Lubricated Male Condom (K160399)Ansell Healthcare Products, LLC2016-07-25
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM (K100767)Church & Dwight Co., Inc.2011-04-05
DUREX SYNTHETIC POLYISOPRENE MALE CONDOM (K072169)Ssl Americas, Inc.2008-06-19
LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM (K070800)Ansell Healthcare Products, LLC2008-03-06
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM (K050828)Church & Dwight Co., Inc.2006-02-28
EZ-ON CONDOM (K001974)Mayer Laboratories2001-10-24
LUBRICATED BAGGY TACTYLON CONDOM (K974121)Sensicon Corp.1998-01-29
TACTYLON CONDOM (K971590)Sensicon Corp.1997-10-07
SPERM PREPARATION MEDIA (K962816)Genx Intl., Inc.1996-11-26
TROJAN POLYURETHANE CONDOM (MODIFICATION) (K955672)Carter Products1996-08-29
TROJAN POLYURETHANE CONDOM (K942697)Carter Products1995-06-22
EXTRA PROTECTION POLYURETHANE CONDOM (K922688)Apex Medical Technologies, Inc.1995-05-04

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Every clearance here is in the API, with alerts when new ones post.