FDA Product Code
FDA Product Code HIS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.5300
510(k) Clearances — 402 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262108 | FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms Aqueous Lubricant (Plain);FAMA Male Latex Condoms Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms Aqueous Lubricant (Dotted);FAMA Male Latex Condoms Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms Aqueous Lubricant (Plain);MO Male Latex Condoms Aqueous Lubricant (Ribbed);MO Male Latex Condoms Aqueous Lubricant (Dotted);MO | Shanghai Personage Hygiene Products Co., Ltd. | 2026-09-21 | Traditional | PDF ↗ |
| K252622 | Male Latex Condom HA | Okamoto USA, Inc. | 2026-05-04 | Abbreviated | PDF ↗ |
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom | Suretex Limited | 2025-11-18 | Abbreviated | PDF ↗ |
| K250034 | Natural rubber latex male condom | Shaoguan Regenex Pharmaceuticals Co., Ltd. | 2025-07-11 | Traditional | PDF ↗ |
| K243421 | Lelo Hex Lubricated Natural Rubber Latex Condom | Lelo, Inc. | 2025-03-07 | Traditional | PDF ↗ |
| K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) | Church & Dwight Co., Inc. | 2025-02-21 | Traditional | PDF ↗ |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | Okamoto USA, Inc. | 2025-02-18 | Abbreviated | PDF ↗ |
| K232279 | LifeStyles NRL Textured Condom | Suretex Limited | 2023-10-05 | Abbreviated | PDF ↗ |
| K230049 | 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 | Ttk Healthcare Limited | 2023-09-07 | Traditional | PDF ↗ |
| K222611 | Male Latex Condoms | Suzhou Colour-Way New Material Co., Ltd. | 2022-11-28 | Traditional | PDF ↗ |
| K220489 | Durex Patronus CloseFit, Durex Patronus Regular | Rb Health (Us), LLC | 2022-11-07 | Traditional | PDF ↗ |
| K222068 | Durex Penck III Regular | Rb Health (Us), LLC | 2022-10-12 | Traditional | PDF ↗ |
| K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condom | Church & Dwight Co., Inc. | 2022-09-28 | Traditional | PDF ↗ |
| K220576 | FAMA Male Latex Condoms | Shanghai Personage Hygiene Products Co., Ltd. | 2022-08-05 | Traditional | PDF ↗ |
| K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant | Church & Dwight Co., Inc. | 2022-07-14 | Traditional | PDF ↗ |
| K211152 | Durex Condom with Benzocaine | Rb Health (Us), LLC | 2022-05-11 | Traditional | PDF ↗ |
| K213921 | Microthin Natural Rubber Latex Condom | Suretex Limited | 2022-04-28 | Abbreviated | PDF ↗ |
| K213647 | Durex Patronus Wide | Rb Health (Us), LLC | 2022-02-17 | Traditional | PDF ↗ |
| K210208 | Titan Condoms | Titan Condoms, LLC | 2022-02-17 | Traditional | PDF ↗ |
| K213547 | SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla | Ttk Healthcare Limited | 2021-12-23 | Special | PDF ↗ |
| K211450 | Playboy 3 Contour Condom | Thai Nippon Rubber Industry Public Company Limited. | 2021-09-30 | Traditional | PDF ↗ |
| K210294 | One Touch Spiral Condom | Thai Nippon Rubber Industry Public Company Limited. | 2021-09-23 | Traditional | PDF ↗ |
| K203536 | Male Latex Condom | Global Protection Corp. | 2021-09-03 | Abbreviated | PDF ↗ |
| K202403 | SKORE (Colors & Flavors), SKORE (Colors) | Ttk Healthcare Limited | 2021-04-15 | Traditional | PDF ↗ |
| K200672 | Durex Penck Standard, Durex Penck XL | Rb Health (Us), LLC | 2020-11-06 | Traditional | PDF ↗ |
| K193578 | Non-spermicidal Lubricated Male Latex Condom | Global Protection Corp. | 2020-08-20 | Abbreviated | PDF ↗ |
| K201067 | CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed)) | Cupid Limited | 2020-08-07 | Abbreviated | PDF ↗ |
| K192669 | Extremely Thin 003, ZERO ZERO THREE | Okamoto USA, Inc. | 2020-07-24 | Abbreviated | PDF ↗ |
| K181844 | One Touch | Thai Nippon Rubber Industry Public Company, Ltd. | 2019-04-15 | Abbreviated | PDF ↗ |
| K180104 | Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant | Church & Dwight Co., Inc. | 2018-03-14 | Traditional | PDF ↗ |
| K171213 | One Touch Condom with Benzocaine | Thai Nippon Rubber Industry Public Company Limited. | 2018-01-12 | Traditional | PDF ↗ |
| K172414 | JUD custom fit condom | Global Mailer Partners, LLC | 2017-10-12 | Abbreviated | PDF ↗ |
| K162919 | Male Latex Condoms | Zhejiang Xiangban Latex Products Co., Ltd. | 2017-03-07 | Traditional | PDF ↗ |
| K163107 | Lifestyles Zero Lubricated Latex Male Condom | Ansell Healthcare Products, LLC | 2017-01-23 | Abbreviated | PDF ↗ |
| K162511 | LELO RESPECT HEX Natural Rubber Latex Condom | Lelo, Inc. | 2017-01-13 | Special | PDF ↗ |
| K153016 | aoni Natural Rubber Latex Condom | Guangzhou Daming United Rubber Products , Ltd. | 2016-10-20 | Abbreviated | PDF ↗ |
| K161915 | Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant | Church & Dwight Co., Inc. | 2016-09-09 | Traditional | PDF ↗ |
| K161545 | Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant | Church & Dwight Co., Inc. | 2016-08-26 | Traditional | PDF ↗ |
| K161195 | Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) | M3 Global Enterprises, LLC | 2016-08-25 | Abbreviated | PDF ↗ |
| K160644 | Lelo Hex Natural Rubber Latex Condom | Lelo, Inc. | 2016-06-30 | Traditional | PDF ↗ |
| K150828 | O-RING Condom | O-Ring Products, LLC | 2015-12-18 | Abbreviated | PDF ↗ |
| K150857 | Banana Gold | Hankook Latex Gongup Co., Ltd. | 2015-08-14 | Traditional | PDF ↗ |
| K150072 | TheyFit Male Condom | Theyfit | 2015-04-14 | Traditional | PDF ↗ |
| K132490 | SKORE AND MULTIPLE BRANDS | Ttk Protective Devices Limited (Formerly Ttk-Lig L | 2014-10-20 | Abbreviated | PDF ↗ |
| K141059 | NATURAL RUBBER LATEX MALE CONDOMS | Karex Industries Sdn. Bhd. | 2014-08-01 | Abbreviated | PDF ↗ |
| K141256 | OKAMOTO STUDDED CONDOM | Okamoto USA, Inc. | 2014-07-23 | Abbreviated | PDF ↗ |
| K140379 | MEGA BIG BOY CONDOM | Okamoto USA, Inc. | 2014-07-01 | Abbreviated | PDF ↗ |
| K131866 | SUSTAIN | Hollender Sustainable Brands, LLC | 2014-05-01 | Abbreviated | PDF ↗ |
| K132390 | INSTINCT; PLAIN, DOTTED, ULTRA THIN | Profilatex, S.A. DE C.V. | 2014-04-22 | Abbreviated | PDF ↗ |
| K132107 | MALE LATEX CONDOM | Nulatex Sdn. Bhd. | 2014-03-07 | Abbreviated | PDF ↗ |
| K132597 | BLACK COLOURED CONDOM | Karex Industries Sdn. Bhd. | 2013-11-25 | Abbreviated | PDF ↗ |
| K131887 | TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT | Church & Dwight Co., Inc. | 2013-10-24 | Traditional | PDF ↗ |
| K122219 | THEYFIT MALE CONDOM | Theyfit | 2013-09-27 | Traditional | PDF ↗ |
| K121241 | MALE LATEX CONDOM | Nulatex Sdn. Bhd. | 2013-02-14 | Abbreviated | PDF ↗ |
| K120555 | LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE) | Medical-Latex (Dua) Sdn. Bhd | 2012-11-02 | Abbreviated | PDF ↗ |
| K113056 | ORANGE COLORED CONDOMS ORANGE SCENT | Karex Industries Sdn. Bhd. | 2012-07-03 | Special | PDF ↗ |
| K120286 | TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT | Church & Dwight Co., Inc. | 2012-06-19 | Traditional | PDF ↗ |
| K120287 | TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT | Church & Dwight Co., Inc. | 2012-05-16 | Traditional | PDF ↗ |
| K120249 | TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT | Church & Dwight Virginia Co., Inc. | 2012-05-11 | Traditional | PDF ↗ |
| K120394 | LIFESTYLES ZERO LUBRICATED LATEX CONDOM | Ansell Heathcare Products, LLC | 2012-05-08 | Abbreviated | PDF ↗ |
| K113686 | KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED | Mayer Laboratories, Inc. | 2012-03-06 | Abbreviated | PDF ↗ |
| K113061 | LARGE/EXTRA LAGRE CONDOM | Karex Industries Sdn. Bhd. | 2011-12-07 | Special | PDF ↗ |
| K111093 | BILLY BOY MALE LATEX CONDOM | Mapa GmbH | 2011-06-03 | Traditional | PDF ↗ |
| K103119 | BILLY BOY MALE LATEX CONDOM | Sheila Pickering PHD | 2011-02-24 | Traditional | PDF ↗ |
| K092586 | MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU | Innolatex (Thailand) Limited | 2010-05-12 | Abbreviated | PDF ↗ |
| K081265 | THAI NIPPON MALE LATEX CONDOM | Thai Nippon Rubber Industry Co., Ltd. | 2009-10-16 | Abbreviated | PDF ↗ |
| K083817 | M. DIOR BRAND | Suzhou Colour-Way Enterprise Development Co., Ltd. | 2009-09-16 | Abbreviated | PDF ↗ |
| K082529 | ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM | Alatech Healthcare, LLC | 2009-05-01 | Abbreviated | PDF ↗ |
| K090259 | OKAMOTO ULTRA THIN | Okamoto USA, Inc. | 2009-03-31 | Abbreviated | PDF ↗ |
| K081886 | KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED | Karex Industries Sdn. Bhd. | 2009-02-06 | Abbreviated | PDF ↗ |
| K081413 | TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM | Dailian Latex Company, Ltd. | 2008-10-24 | Traditional | PDF ↗ |
| K080833 | LOVE GUARD MALE LATEX CONDOM | Tianjin Human-Care Latex Corporation | 2008-08-07 | Abbreviated | PDF ↗ |
| K070511 | RICHTER MALE LATEX CONDOM | Richter Rubber Technology Sbn Bhd | 2008-01-14 | Abbreviated | PDF ↗ |
| K072747 | UNIDUS MAGNUM MALE LATEX CONDOM | Unidus Corp. | 2007-11-15 | Abbreviated | PDF ↗ |
| K073016 | TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT | Church & Dwight Co., Inc. | 2007-11-09 | Abbreviated | PDF ↗ |
| K071313 | TROJAN-ENZ BRAND | Church & Dwight Co., Inc. | 2007-10-26 | Abbreviated | PDF ↗ |
| K070937 | MULTIPLE BRAND MALE LATEX CONDOM | Nulatex Sdn. Bhd. | 2007-09-21 | Abbreviated | PDF ↗ |
| K071272 | TROJAN THINTENSITY BRAND MALE LATEX CONDOM | Church & Dwight Co., Inc. | 2007-09-12 | Abbreviated | PDF ↗ |
| K070830 | MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING) | Karex Industries Sdn. Bhd. | 2007-05-08 | Abbreviated | PDF ↗ |
| K063401 | BANANA RIBBED | Medtech Products , Ltd. | 2007-03-26 | Abbreviated | PDF ↗ |
| K062730 | NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS | Biogreen Medical Sdn. Bhd. | 2006-10-05 | Abbreviated | PDF ↗ |
| K052206 | ZEUS MALE CONDOM APPLICATOR | Condax, LLC | 2006-09-12 | Abbreviated | PDF ↗ |
| K051842 | GREEN LOVE MALE CONTRACEPTIVE (CONDOM) | Cupid Condom, Ltd. | 2006-04-14 | Abbreviated | PDF ↗ |
| K060797 | NAKED | Veraxis Int'L, Inc. | 2006-04-07 | Traditional | PDF ↗ |
| K050913 | DICK'S FORMALWEAR MALE LATEX CONDOM | Dick'S Formalwear, Inc. | 2006-04-04 | Traditional | PDF ↗ |
| K053367 | MALE NATURAL RUBBER LATEX CONDOM | Innolatex Sdn. Bhd | 2006-02-21 | Abbreviated | PDF ↗ |
| K051288 | VIELLE LUBRICANT | Cst Medical Limited | 2006-02-03 | Traditional | PDF ↗ |
| K052959 | DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS | Ssl Americas | 2006-01-27 | Abbreviated | PDF ↗ |
| K051273 | DIVAS DUAL PLEASURE MALE LATEX CONDOM | Eagle Twe, Inc. | 2005-08-19 | Abbreviated | PDF ↗ |
| K050244 | MALE NATURAL RUBBER LATEX CONDOM | Nrs Global Partners | 2005-04-08 | Abbreviated | PDF ↗ |
| K042470 | DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM | Ssl Americas, Inc. | 2005-04-05 | Abbreviated | PDF ↗ |
| K050360 | TULIP CONDOM | Shanghai Latex Factory | 2005-03-01 | Traditional | PDF ↗ |
| K042957 | DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT | Ssl Americas | 2005-02-17 | Abbreviated | PDF ↗ |
| K041717 | POWERSTICK MALE LATEX CONDOMS | A.P.Deauville, LLC | 2005-01-13 | Abbreviated | PDF ↗ |
| K041667 | SAN-MAR LABS LUBRICATING JELLY | San-Mar Laboratories, Inc. | 2005-01-13 | Traditional | PDF ↗ |
| K041432 | ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT | Biofilm, Inc. | 2004-11-30 | Traditional | PDF ↗ |
| K041837 | INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED | Innolatex Sdn. Bhd | 2004-09-24 | Abbreviated | PDF ↗ |
| K040185 | DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM | Ssl Americas | 2004-04-27 | Abbreviated | PDF ↗ |
| K040085 | PERSONAL WARMING LUBRICANT | Qualis, Inc. | 2004-04-20 | Traditional | PDF ↗ |
| K032227 | DUREX FLAVORED LATEX CONDOM | Ssl Americas, Inc. | 2004-03-29 | Abbreviated | PDF ↗ |
Product code HIS · Class II · Obstetrics/Gynecology. Data: openFDA.