ClearanceBrief
Panels › Obstetrics/Gynecology › Product code HIS · Class 2

Condom

Regulation 884.5300

3510(k)s in 12 months (402 all time)
1recalls in 12 months (7 all time)
4recalls that name a 510(k)
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Top companies in HIS

Company510(k)sRecalls
Carter Products150
Mayer Laboratories140
Okamoto USA, Inc.140
Ansell, Inc.120
Church & Dwight Co., Inc.120
Remed Pharma90
Schmid Laboratories, Inc.90
Innolatex Sdn. Bhd80
Pleasure Latex Products Sdn. Bhd.80
Suretex Limited80
Decided510(k)Device and applicantCode
Sep 21, 2026K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male L
Shanghai Personage Hygiene Products Co., Ltd., CN
HIS
May 4, 2026K252622Male Latex Condom HA
Okamoto USA, Inc.
HIS
Nov 18, 2025K252521LifeStyles® HydraFeel Natural Rubber Latex Condom
Suretex Limited, TH
HIS
Jul 11, 2025K250034Natural rubber latex male condom
Shaoguan Regenex Pharmaceuticals Co., Ltd., CN
HIS
Mar 7, 2025K243421Lelo Hex Lubricated Natural Rubber Latex Condom
Lelo, Inc.
HIS
Feb 21, 2025K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)
Church & Dwight Co., Inc.
HIS
Feb 18, 2025K2435840.04 ZERO ZERO FOUR Male Latex Condom
Okamoto USA, Inc.
HIS
Oct 5, 2023K232279LifeStyles NRL Textured Condom
Suretex Limited, TH
HIS
Sep 7, 2023K230049SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE N
Ttk Healthcare Limited, IN
HIS
Nov 28, 2022K222611Male Latex Condoms
Suzhou Colour-Way New Material Co., Ltd., CN
HIS
Nov 7, 2022K220489Durex Patronus CloseFit, Durex Patronus Regular
Rb Health (Us), LLC
HIS
Oct 12, 2022K222068Durex Penck III Regular
Rb Health (Us), LLC
HIS
Sep 28, 2022K221906TROJAN Fire & Ice lubricated male natural rubber latex condom
Church & Dwight Co., Inc.
HIS
Aug 5, 2022K220576FAMA Male Latex Condoms
Shanghai Personage Hygiene Products Co., Ltd., CN
HIS
Jul 14, 2022K221431TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant
Church & Dwight Co., Inc.
HIS
May 11, 2022K211152Durex Condom with Benzocaine
Rb Health (Us), LLC
HIS
Apr 28, 2022K213921Microthin Natural Rubber Latex Condom
Suretex Limited, TH
HIS
Feb 17, 2022K213647Durex Patronus Wide
Rb Health (Us), LLC
HIS
Feb 17, 2022K210208Titan Condoms
Titan Condoms, LLC
HIS
Dec 23, 2021K213547SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla
Ttk Healthcare Limited, IN
HIS
Sep 30, 2021K211450Playboy 3 Contour Condom
Thai Nippon Rubber Industry Public Company Limited., TH
HIS
Sep 23, 2021K210294One Touch Spiral Condom
Thai Nippon Rubber Industry Public Company Limited., TH
HIS
Sep 3, 2021K203536Male Latex Condom
Global Protection Corp.
HIS
Apr 15, 2021K202403SKORE (Colors & Flavors), SKORE (Colors)
Ttk Healthcare Limited, IN
HIS
Nov 6, 2020K200672Durex Penck Standard, Durex Penck XL
Rb Health (Us), LLC
HIS
Aug 20, 2020K193578Non-spermicidal Lubricated Male Latex Condom
Global Protection Corp.
HIS
Aug 7, 2020K201067CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Cont
Cupid Limited, IN
HIS
Jul 24, 2020K192669Extremely Thin 003, ZERO ZERO THREE
Okamoto USA, Inc.
HIS
Apr 15, 2019K181844One Touch
Thai Nippon Rubber Industry Public Company, Ltd., TH
HIS
Mar 14, 2018K180104Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant
Church & Dwight Co., Inc.
HIS
Jan 12, 2018K171213One Touch Condom with Benzocaine
Thai Nippon Rubber Industry Public Company Limited., TH
HIS
Oct 12, 2017K172414JUD custom fit condom
Global Mailer Partners, LLC
HIS
Mar 7, 2017K162919Male Latex Condoms
Zhejiang Xiangban Latex Products Co., Ltd., CN
HIS
Jan 23, 2017K163107Lifestyles Zero Lubricated Latex Male Condom
Ansell Healthcare Products, LLC
HIS
Jan 13, 2017K162511LELO RESPECT HEX Natural Rubber Latex Condom
Lelo, Inc.
HIS
Oct 20, 2016K153016aoni Natural Rubber Latex Condom
Guangzhou Daming United Rubber Products , Ltd., CN
HIS
Sep 9, 2016K161915Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
Church & Dwight Co., Inc.
HIS
Aug 26, 2016K161545Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
Church & Dwight Co., Inc.
HIS
Aug 25, 2016K161195Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
M3 Global Enterprises, LLC
HIS
Jun 30, 2016K160644Lelo Hex Natural Rubber Latex Condom
Lelo, Inc.
HIS
Dec 18, 2015K150828O-RING Condom
O-Ring Products, LLC
HIS
Aug 14, 2015K150857Banana Gold
Hankook Latex Gongup Co., Ltd., KR
HIS
Apr 14, 2015K150072TheyFit Male Condom
Theyfit
HIS
Oct 20, 2014K132490SKORE AND MULTIPLE BRANDS
Ttk Protective Devices Limited (Formerly Ttk-Lig L
HIS
Aug 1, 2014K141059NATURAL RUBBER LATEX MALE CONDOMS
Karex Industries Sdn. Bhd., MY
HIS
Jul 23, 2014K141256OKAMOTO STUDDED CONDOM
Okamoto USA, Inc.
HIS
Jul 1, 2014K140379MEGA BIG BOY CONDOM
Okamoto USA, Inc.
HIS
May 1, 2014K131866SUSTAIN
Hollender Sustainable Brands, LLC
HIS
Apr 22, 2014K132390INSTINCT; PLAIN, DOTTED, ULTRA THIN
Profilatex, S.A. DE C.V., MX
HIS
Mar 7, 2014K132107MALE LATEX CONDOM
Nulatex Sdn. Bhd., MY
HIS

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