Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Condom

FDA product code HIS · 392 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.5300
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-06-17 – 2026-09-21

HIS 1997-01-22

OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODIT,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN

Applicant Custom Services Intl., Inc.

K number K963319

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HIS 1996-12-12

LOVING SMARTER - SAFER SEX

Applicant Loving Smarter, Inc.

K number K963679

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HIS 1996-10-10

CONDOM

Applicant Polar Latex , Ltd.

K number K960710

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HIS 1996-07-15

TRUSTEX FLAVOR CONDON IN COLORS

Applicant Line One Laboratories & Trading Co.

K number K946103

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HIS 1996-06-21

K-Y PERSONAL LUBRICANT

Applicant Ortho Pharmaceutical Corp.

K number K955648

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HIS 1996-02-21

RIA LATEX CONDOM, NONOXYNOL-9

Applicant Mbf Personal Care Sdn. Bhd.

K number K945145

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HIS 1996-02-13

RIA LATEX CONDOM

Applicant Mbf Personal Care Sdn. Bhd.

K number K943880

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HIS 1996-01-26

LUBRICATED CONDOM

Applicant Tactyl Technologies, Inc.

K number K953583

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HIS 1996-01-24

CONQUEROR, RUMBA AND TEMPTATION

Applicant Frontline Latex Products Pvt. , Ltd.

K number K946207

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HIS 1996-01-05

SEMINAL FLUID COLLECTION KIT II

Applicant Apex Medical Technologies, Inc.

K number K954791

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HIS 1995-12-19

RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE

Applicant Line One Laboratories & Trading Co.

K number K945930

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HIS 1995-12-19

SPERMICIDALLY LUBRICATED CONDOM

Applicant Ansell, Inc.

K number K940047

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HIS 1995-12-06

RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK)

Applicant Line One Laboratories & Trading Co.

K number K944786

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HIS 1995-12-06

LATEX CONDOM

Applicant Suretex, Ltd.

K number K941258

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HIS 1995-11-22

PROBE PERSONAL LUBRICANT - SILKY LIGHT

Applicant Davryan Laboratories, Inc.

K number K952465

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HIS 1995-11-22

PROBE PERSONAL LUBRICANT - CLASSIC

Applicant Davryan Laboratories, Inc.

K number K952464

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HIS 1995-11-08

KIMONO MICROTHIN

Applicant Mayer Laboratories

K number K946374

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HIS 1995-09-22

MAXX

Applicant Mayer Laboratories

K number K946376

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HIS 1995-09-22

KIMONO (CONDOMS)

Applicant Mayer Laboratories

K number K943064

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HIS 1995-09-07

PREVENTOR AND PROTECTOR LATEX CONDOMS

Applicant American Pharmaceutical Co., Inc.

K number K945246

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HIS 1995-08-09

OKAMOTO CONDOM

Applicant Okamoto USA, Inc.

K number K952393

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HIS 1995-06-22

SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM

Applicant Aladan Corp.

K number K943933

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HIS 1995-06-16

AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI

Applicant Sime Health, Ltd.

K number K932985

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HIS 1995-05-18

LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9)

Applicant Suretex, Ltd.

K number K942858

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HIS 1995-04-14

SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM

Applicant Aladan Corp.

K number K943883

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HIS 1995-01-30

NON-LUBRICATED CONDOM

Applicant Ansell, Inc.

K number K940046

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HIS 1995-01-30

CONDOM

Applicant Ansell, Inc.

K number K940045

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HIS 1995-01-03

LUBRICATING JELLY

Applicant Barre-National, Inc.

K number K941831

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HIS 1994-12-27

TACTYLON(TM) CONDOM

Applicant Tactyl Technologies, Inc.

K number K911431

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HIS 1994-09-14

LATEX PROPHYLACTIC RUBBER CONTRACEPTIVE

Applicant J.K. Chemicals, Ltd.

K number K931077

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HIS 1994-07-28

PENTHOUSE CONDOMS

Applicant Kuron Health Products Corp.

K number K933153

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HIS 1994-07-07

UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI

Applicant Sime Health, Ltd.

K number K932984

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HIS 1994-07-07

COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)

Applicant Sime Health, Ltd.

K number K932983

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HIS 1994-07-07

SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)

Applicant Sime Health, Ltd.

K number K932982

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HIS 1994-02-22

SPIRAL

Applicant Thornton Associates, Inc.

K number K920514

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HIS 1993-09-01

CONDOOM SHELF LIFE -- MODIFICATIONS

Applicant Safetex Corp.

K number K922889

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HIS 1992-07-21

LATEX PROPHYLACTIC (CONDOM)

Applicant Hevealactics Intl. Sdn Bhd

K number K912405

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HIS 1992-06-01

JIFFI CONDOM (RUBBER) CONTRACEPTIVE

Applicant Sime Health, Ltd.

K number K913813

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HIS 1992-02-03

TROJAN (TM-TBD) CONDOM

Applicant Carter Products

K number K912901

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HIS 1991-12-18

CONDOMS, MOODS/SHARE & RAKSHAK

Applicant Hindustan Latex , Ltd.

K number K910470

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HIS 1991-08-14

PLEASURE PLUS

Applicant Medimix Products, Inc.

K number K902772

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HIS 1991-06-04

CONDOMS (RUBBER CONTRACEPTIVES)

Applicant Suretex, Ltd.

K number K910284

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HIS 1991-06-03

CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW

Applicant Safetex Corp.

K number K910550

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HIS 1991-05-09

CMI TENDER TOUCH VE #303TT AND 404TT

Applicant Challenge Mfg., Inc.

K number K910788

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HIS 1991-04-03

MCLAUGHLIN LAPAROSCOPIC GRASPER

Applicant Marlo Surgical Technology

K number K910578

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HIS 1991-03-29

TP AND DESIGN, CONDOM

Applicant China National Medicines & Health Prod. I/E Corp.

K number K902324

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HIS 1991-03-29

TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.

Applicant Armkel, LLC

K number K902305

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HIS 1991-03-06

POLYURETHANE CONDOM

Applicant Apex Medical Technologies, Inc.

K number K902936

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HIS 1991-02-19

CONDOM (RUBBER) CONTRACEPTIVE

Applicant Aladan Corp.

K number K905279

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HIS 1991-02-19

TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR

Applicant Armkel, LLC

K number K904000

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HIS 1991-02-15

CONDOMS

Applicant Barnetts, Inc.

K number K905854

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HIS 1990-12-21

MAMBA CONDOM (RUBBER LATEX)

Applicant Rfsu

K number K902907

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HIS 1990-12-19

GUARDIAN & JANITEX CONDOM/PROPHYLACTIC

Applicant Allied Rubber Industries Sdn. Bhd.

K number K896098

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HIS 1990-11-26

KIMONO PLUS

Applicant Mayer Laboratories

K number K904375

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HIS 1990-11-23

LABELLING MODIFICATION TO MAXX PLUS

Applicant Mayer Laboratories

K number K904453

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HIS 1990-11-20

ORION PLUS/MODIFICATION

Applicant Mayer Laboratories

K number K904840

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HIS 1990-08-13

EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT

Applicant Okamoto USA, Inc.

K number K902804

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HIS 1990-07-24

SAXON RIBBED CONDOMS

Applicant Safetex Corp.

K number K902509

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HIS 1990-07-13

THIN CONDOM RAMSES & SHEIK

Applicant Schmid Laboratories, Inc.

K number K897140

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HIS 1990-06-29

RUBBER CONTRACEPTIVE

Applicant Banrub Sdn Bhd

K number K896107

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HIS 1990-06-19

TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED

Applicant Carter Products

K number K901202

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HIS 1990-06-07

MINT SCENTED CONDOMS

Applicant Schmid Laboratories, Inc.

K number K900679

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HIS 1990-06-06

RUBBER CONDOM (NON-COLORED)

Applicant Hankook Latex Gongup Co., Ltd.

K number K896987

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HIS 1990-06-06

RUBBER CONTRACEPTIVE (CONDOM)

Applicant Guangzhou No. 11 Rubber Factory

K number K896142

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HIS 1990-06-04

CONDOM (RUBBER) CONTRACEPTIVE

Applicant Aladan Corp.

K number K901416

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HIS 1990-05-16

LATEX CONDOMS - CODE NO. 403, 406, 421 & 1033

Applicant Allercare/Nsl, Inc.

K number K901696

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HIS 1990-05-16

LATEX CONDOMS - CODE NO. 404, NO. 424 & NO. 1000

Applicant Allercare/Nsl, Inc.

K number K901669

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HIS 1990-05-16

LATEX CONDOMS - CODE NO. 402, CODE NO. 1028

Applicant Allercare/Nsl, Inc.

K number K901668

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HIS 1990-05-16

LATEX CONDOMS - CODE NO. 401, 421 & 1002

Applicant Allercare/Nsl, Inc.

K number K901667

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HIS 1990-05-16

CONDOMS (MULTIPLE BRANDS)

Applicant Sagami, Inc.

K number K897129

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HIS 1990-05-04

CONDOM (RUBBER) CONTRACEPTIVE

Applicant Chinteik Hygiene Products Co., Ltd.

K number K893039

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HIS 1990-04-16

TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED

Applicant Carter Products

K number K901201

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HIS 1990-04-16

TROJAN FOR WOMEN LATEX CONDOMS W/SPERMI. MODIFIED

Applicant Carter Products

K number K901200

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HIS 1990-04-16

TROJAN-ENZ LATEX CONDOMS W/SPERMICIDAL MODIFIED

Applicant Carter Products

K number K901199

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HIS 1990-04-16

TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED

Applicant Carter Products

K number K901198

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HIS 1990-04-16

TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL

Applicant Carter Products

K number K901197

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HIS 1990-04-16

TROJAN FOR WOMEN LUBRI. CONDOMS MODIFIED LABELING

Applicant Carter Products

K number K901196

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HIS 1990-04-16

TROJAN RIBBED NATURALUBE LUBRI. CONDOMS MODIFIED

Applicant Carter Products

K number K901195

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HIS 1990-04-16

TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL

Applicant Carter Products

K number K901194

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HIS 1990-04-16

TROJAN PLUS LUBRI. LATEX CONDOMS (MODIFIED LABEL)

Applicant Carter Products

K number K901193

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HIS 1990-04-16

TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING)

Applicant Carter Products

K number K901192

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HIS 1990-04-16

TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING)

Applicant Carter Products

K number K901191

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HIS 1990-04-16

TROJANS LATEX CONDOMS (MODIFIED LABELING)

Applicant Carter Products

K number K901190

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HIS 1990-04-02

SAXON ULTRA THIN

Applicant Safetex Corp.

K number K900360

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HIS 1990-04-02

EMBRACE

Applicant Safetex Corp.

K number K900359

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HIS 1990-04-02

SAXON WET LUBE

Applicant Safetex Corp.

K number K900358

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HIS 1990-04-02

GOLD CIRCLE COIN

Applicant Safetex Corp.

K number K900357

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HIS 1990-03-27

G.S.A. COLORED CONDOMS

Applicant Ansell, Inc.

K number K901112

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HIS 1990-03-27

NUDA (CURRENTLY CALLED ULTRA SENSITIVE)

Applicant Ansell, Inc.

K number K901111

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HIS 1990-02-16

SAFECON CONDOMS - PINK COLOR

Applicant Quality Synthetics Intl, Inc.

K number K896623

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HIS 1990-01-23

MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT

Applicant Armkel, LLC

K number K895640

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HIS 1990-01-16

RIA (CONDOM)

Applicant La Technology Sdn. Bhd.

K number K895091

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HIS 1990-01-10

MODIFIED LABELING ON OKAMOTO HARMONY CONDOM

Applicant Okamoto USA, Inc.

K number K896339

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HIS 1990-01-10

LATEX PROPHYLACTIC/RUBBER CONTRACEPTIVE

Applicant Shinhen Corp.

K number K893217

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HIS 1989-12-18

CONDOM (RUBBER LATEX) KILROY

Applicant Rfsu

K number K894533

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HIS 1989-12-14

PROFIL CONDOM (RUBBER LATEX)

Applicant Rfsu

K number K895894

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HIS 1989-12-14

BIRDS'N BEES CONDOMS

Applicant Rfsu

K number K895028

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HIS 1989-12-14

CONDOM (RUBBER LATEX) OKEIDO

Applicant Rfsu

K number K894534

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HIS 1989-11-28

STANDARD CONDOM

Applicant Mayer Laboratories

K number K895530

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HIS 1989-09-12

THE SAFEGARD PERSONAL PROTECTION KIT

Applicant The Safegard Protection Corp.

K number K884692

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