Atlas FDA

HIS

401 FDA 510(k) clearances · Product code

115 daysmedian time to decision
330 days90th percentile
401clearances measured

FDA profile

Official device name
Condom
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5300
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2018: 11 · 2019: 15 · 2020: 12 · 2021: 16 · 2022: 18 · 2025: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Male Latex Condom HA (K252622)Okamoto USA, Inc.2026-05-04
LifeStyles® HydraFeel Natural Rubber Latex Condom (K252521)Suretex Limited2025-11-18
Natural rubber latex male condom (K250034)Shaoguan Regenex Pharmaceuticals Co., Ltd.2025-07-11
Lelo Hex Lubricated Natural Rubber Latex Condom (K243421)Lelo, Inc.2025-03-07
Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) (K243640)Church & Dwight Co., Inc.2025-02-21
0.04 ZERO ZERO FOUR Male Latex Condom (K243584)Okamoto USA, Inc.2025-02-18
LifeStyles NRL Textured Condom (K232279)Suretex Limited2023-10-05
SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT (K230049)Ttk Healthcare Limited2023-09-07
Male Latex Condoms (K222611)Suzhou Colour-Way New Material Co., Ltd.2022-11-28
Durex Patronus CloseFit, Durex Patronus Regular (K220489)Rb Health (Us), LLC2022-11-07
Durex Penck III Regular (K222068)Rb Health (Us), LLC2022-10-12
TROJAN Fire & Ice lubricated male natural rubber latex condom (K221906)Church & Dwight Co., Inc.2022-09-28
FAMA Male Latex Condoms (K220576)Shanghai Personage Hygiene Products Co., Ltd.2022-08-05
TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant (K221431)Church & Dwight Co., Inc.2022-07-14
Durex Condom with Benzocaine (K211152)Rb Health (Us), LLC2022-05-11
Microthin Natural Rubber Latex Condom (K213921)Suretex Limited2022-04-28
Titan Condoms (K210208)Titan Condoms, LLC2022-02-17
Durex Patronus Wide (K213647)Rb Health (Us), LLC2022-02-17
SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla (K213547)Ttk Healthcare Limited2021-12-23
Playboy 3 Contour Condom (K211450)Thai Nippon Rubber Industry Public Company Limited.2021-09-30
One Touch Spiral Condom (K210294)Thai Nippon Rubber Industry Public Company Limited.2021-09-23
Male Latex Condom (K203536)Global Protection Corp.2021-09-03
SKORE (Colors & Flavors), SKORE (Colors) (K202403)Ttk Healthcare Limited2021-04-15
Durex Penck Standard, Durex Penck XL (K200672)Rb Health (Us), LLC2020-11-06
Non-spermicidal Lubricated Male Latex Condom (K193578)Global Protection Corp.2020-08-20
CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed)) (K201067)Cupid Limited2020-08-07
Extremely Thin 003, ZERO ZERO THREE (K192669)Okamoto USA, Inc.2020-07-24
One Touch (K181844)Thai Nippon Rubber Industry Public Company, Ltd.2019-04-15
Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant (K180104)Church & Dwight Co., Inc.2018-03-14
One Touch Condom with Benzocaine (K171213)Thai Nippon Rubber Industry Public Company Limited.2018-01-12
JUD custom fit condom (K172414)Global Mailer Partners, LLC2017-10-12
Male Latex Condoms (K162919)Zhejiang Xiangban Latex Products Co., Ltd.2017-03-07
Lifestyles Zero Lubricated Latex Male Condom (K163107)Ansell Healthcare Products, LLC2017-01-23
LELO RESPECT HEX Natural Rubber Latex Condom (K162511)Lelo, Inc.2017-01-13
aoni Natural Rubber Latex Condom (K153016)Guangzhou Daming United Rubber Products , Ltd.2016-10-20
Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant (K161915)Church & Dwight Co., Inc.2016-09-09
Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant (K161545)Church & Dwight Co., Inc.2016-08-26
Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) (K161195)M3 Global Enterprises, LLC2016-08-25
Lelo Hex Natural Rubber Latex Condom (K160644)Lelo, Inc.2016-06-30
O-RING Condom (K150828)O-Ring Products, LLC2015-12-18
Banana Gold (K150857)Hankook Latex Gongup Co., Ltd.2015-08-14
TheyFit Male Condom (K150072)Theyfit2015-04-14
SKORE AND MULTIPLE BRANDS (K132490)Ttk Protective Devices Limited (Formerly Ttk-Lig L2014-10-20
NATURAL RUBBER LATEX MALE CONDOMS (K141059)Karex Industries Sdn. Bhd.2014-08-01
OKAMOTO STUDDED CONDOM (K141256)Okamoto USA, Inc.2014-07-23
MEGA BIG BOY CONDOM (K140379)Okamoto USA, Inc.2014-07-01
SUSTAIN (K131866)Hollender Sustainable Brands, LLC2014-05-01
INSTINCT; PLAIN, DOTTED, ULTRA THIN (K132390)Profilatex, S.A. DE C.V.2014-04-22
MALE LATEX CONDOM (K132107)Nulatex Sdn. Bhd.2014-03-07
BLACK COLOURED CONDOM (K132597)Karex Industries Sdn. Bhd.2013-11-25
TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT (K131887)Church & Dwight Co., Inc.2013-10-24
THEYFIT MALE CONDOM (K122219)Theyfit2013-09-27
MALE LATEX CONDOM (K121241)Nulatex Sdn. Bhd.2013-02-14
LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE) (K120555)Medical-Latex (Dua) Sdn. Bhd2012-11-02
ORANGE COLORED CONDOMS ORANGE SCENT (K113056)Karex Industries Sdn. Bhd.2012-07-03
TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT (K120286)Church & Dwight Co., Inc.2012-06-19
TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT (K120287)Church & Dwight Co., Inc.2012-05-16
TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT (K120249)Church & Dwight Virginia Co., Inc.2012-05-11
LIFESTYLES ZERO LUBRICATED LATEX CONDOM (K120394)Ansell Heathcare Products, LLC2012-05-08
KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED (K113686)Mayer Laboratories, Inc.2012-03-06
LARGE/EXTRA LAGRE CONDOM (K113061)Karex Industries Sdn. Bhd.2011-12-07
BILLY BOY MALE LATEX CONDOM (K111093)Mapa GmbH2011-06-03
BILLY BOY MALE LATEX CONDOM (K103119)Sheila Pickering PHD2011-02-24
MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU (K092586)Innolatex (Thailand) Limited2010-05-12
THAI NIPPON MALE LATEX CONDOM (K081265)Thai Nippon Rubber Industry Co., Ltd.2009-10-16
M. DIOR BRAND (K083817)Suzhou Colour-Way Enterprise Development Co., Ltd.2009-09-16
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM (K082529)Alatech Healthcare, LLC2009-05-01
OKAMOTO ULTRA THIN (K090259)Okamoto USA, Inc.2009-03-31
KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED (K081886)Karex Industries Sdn. Bhd.2009-02-06
TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM (K081413)Dailian Latex Company, Ltd.2008-10-24
LOVE GUARD MALE LATEX CONDOM (K080833)Tianjin Human-Care Latex Corporation2008-08-07
RICHTER MALE LATEX CONDOM (K070511)Richter Rubber Technology Sbn Bhd2008-01-14
UNIDUS MAGNUM MALE LATEX CONDOM (K072747)Unidus Corp.2007-11-15
TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT (K073016)Church & Dwight Co., Inc.2007-11-09
TROJAN-ENZ BRAND (K071313)Church & Dwight Co., Inc.2007-10-26
MULTIPLE BRAND MALE LATEX CONDOM (K070937)Nulatex Sdn. Bhd.2007-09-21
TROJAN THINTENSITY BRAND MALE LATEX CONDOM (K071272)Church & Dwight Co., Inc.2007-09-12
MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING) (K070830)Karex Industries Sdn. Bhd.2007-05-08
BANANA RIBBED (K063401)Medtech Products , Ltd.2007-03-26
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS (K062730)Biogreen Medical Sdn. Bhd.2006-10-05
ZEUS MALE CONDOM APPLICATOR (K052206)Condax, LLC2006-09-12
GREEN LOVE MALE CONTRACEPTIVE (CONDOM) (K051842)Cupid Condom, Ltd.2006-04-14
NAKED (K060797)Veraxis Int'L, Inc.2006-04-07
DICK'S FORMALWEAR MALE LATEX CONDOM (K050913)Dick'S Formalwear, Inc.2006-04-04
MALE NATURAL RUBBER LATEX CONDOM (K053367)Innolatex Sdn. Bhd2006-02-21
VIELLE LUBRICANT (K051288)Cst Medical Limited2006-02-03
DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS (K052959)Ssl Americas2006-01-27
DIVAS DUAL PLEASURE MALE LATEX CONDOM (K051273)Eagle Twe, Inc.2005-08-19
MALE NATURAL RUBBER LATEX CONDOM (K050244)Nrs Global Partners2005-04-08
DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM (K042470)Ssl Americas, Inc.2005-04-05
TULIP CONDOM (K050360)Shanghai Latex Factory2005-03-01
DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT (K042957)Ssl Americas2005-02-17
SAN-MAR LABS LUBRICATING JELLY (K041667)San-Mar Laboratories, Inc.2005-01-13
POWERSTICK MALE LATEX CONDOMS (K041717)A.P.Deauville, LLC2005-01-13
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT (K041432)Biofilm, Inc.2004-11-30
INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED (K041837)Innolatex Sdn. Bhd2004-09-24
DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM (K040185)Ssl Americas2004-04-27
PERSONAL WARMING LUBRICANT (K040085)Qualis, Inc.2004-04-20
DUREX FLAVORED LATEX CONDOM (K032227)Ssl Americas, Inc.2004-03-29
DUREX PLAY LUBRICANT (K032124)Ssl Americas, Inc.2004-01-16
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