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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 1989-08-11

CONDOMS

Applicant Universal Trade, Inc.

K number K880819

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HIS 1989-06-23

THE GREAT WALL CONDOM

Applicant Pacific Sales & Development Corp.

K number K884925

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HIS 1989-06-20

HSV-CHECK(TM) TEST KIT

Applicant Diagnostic Technology, Inc.

K number K890819

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HIS 1989-05-16

THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION

Applicant Circle Rubber Corp.

K number K890407

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HIS 1989-04-25

SAFECON CONDOMS - RIBBED

Applicant Quality Synthetics Intl, Inc.

K number K884454

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HIS 1989-04-04

TROJAN FOR WOMEN

Applicant Armkel, LLC

K number K890863

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HIS 1989-03-31

KIMONO PLUS OTHERS (MULTIPLE) CONDOMS

Applicant Mayer Laboratories

K number K884470

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HIS 1989-03-31

ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS

Applicant Mayer Laboratories

K number K884469

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HIS 1989-03-31

SUPER MAXX OTHERS (MULTIPLE) CONDOMS

Applicant Mayer Laboratories

K number K884468

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HIS 1989-03-29

SAFECON CONDOMS W/SPERMICIDAL LUBRICANT

Applicant Quality Synthetics Intl, Inc.

K number K883524

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HIS 1989-03-13

AEGIS(TM) CONDOMS

Applicant Green Cross Medical Supplies Corp.

K number K883409

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HIS 1989-03-10

EXTRA STRENGTH SKIN LESS SKIN CONDOM

Applicant Okamoto USA, Inc.

K number K884402

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HIS 1989-03-01

STANDARD LATEX CONDOM

Applicant Schmid Laboratories, Inc.

K number K884399

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HIS 1989-03-01

SENSATIONS BRAND CONDOMS

Applicant Apex Medical Technologies, Inc.

K number K871358

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HIS 1989-01-12

SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT

Applicant Okamoto USA, Inc.

K number K884401

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HIS 1988-12-08

TROJAN EXTRA STRENGTH LUBRICATED

Applicant Carter Products

K number K883413

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HIS 1988-10-26

THE SAXON SPERMICIDAL CONDOM

Applicant Circle Rubber Corp.

K number K883467

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HIS 1988-10-26

CONDOMS (RAMSES, SHEIK AND KOROMEX)

Applicant Schmid Laboratories, Inc.

K number K882893

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HIS 1988-10-20

KISS OF MINT(TM) NON-LUBRICATED CONDOM

Applicant Ansell, Inc.

K number K882389

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HIS 1988-09-21

KING KONDOM (CONDOM)

Applicant King Kondom Products, Inc.

K number K882009

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HIS 1988-07-08

CONDOM

Applicant Glnic Corp.

K number K881100

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HIS 1988-07-05

CONDOM

Applicant Iris Medical Ent., Inc.

K number K881735

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HIS 1988-07-01

APOLLO CONDOM

Applicant Apollo Enterprise, Ltd. Co.

K number K874236

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HIS 1988-06-29

(CHOICE) ALSO (KONDUM)

Applicant Select Sources, Inc.

K number K880919

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HIS 1988-06-27

NEW JELLIACOAT

Applicant K&G Import/Export Co.

K number K880189

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HIS 1988-06-21

OKAMOTO CONDOMS SPERMICIDALLY LUBRICATED

Applicant Schmid Laboratories, Inc.

K number K880820

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HIS 1988-06-17

DUET (CONDOMS)

Applicant American Laboratories, Inc.

K number K880185

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HIS 1988-06-13

CONDOM (PROPHYLACTIC)

Applicant Health Technologies Intl.

K number K880463

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HIS 1988-05-13

HEADFIRST (CONDOM)

Applicant Stual Products, Inc.

K number K874921

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HIS 1988-05-10

AIDS SAFETY BELT

Applicant Aids Safety Belt, Inc.

K number K875068

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HIS 1988-04-12

CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX)

Applicant Schmid Laboratories, Inc.

K number K874791

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HIS 1988-04-12

BLAUSIEGEL TRANSPARENT CONDOMS

Applicant Ticosan, Inc.

K number K871267

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HIS 1988-04-06

SAFECON CONDOMS

Applicant Quality Synthetics Intl, Inc.

K number K874399

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HIS 1988-04-06

CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)

Applicant Mayer Laboratories

K number K872356

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HIS 1988-03-09

CONTATTO CONDOMS

Applicant Razi Corp.

K number K871744

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HIS 1988-03-07

MENTOR PLUS (CONDOM)

Applicant Arcon Corp.

K number K874383

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HIS 1988-02-26

OKAMOTO CONDOMS

Applicant Schmid Laboratories, Inc.

K number K880202

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HIS 1988-02-26

RUBBER CONTRACEPTIVE, LATEX CONDOMS

Applicant Okamoto USA, Inc.

K number K875111

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HIS 1988-01-21

XL-4 PAGODA (CONDOMS)

Applicant Mayer Laboratories

K number K874851

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HIS 1988-01-19

CONDOM (PROPHYLACTIC)

Applicant Pactec, Inc.

K number K874135

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HIS 1987-12-11

LOVIEL CONDOM

Applicant Lloviel Marketing Corp.

K number K872861

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HIS 1987-12-08

STANDARD LATEX CONDOMS (RAMSES, SHEIK AND KOROMEX)

Applicant Schmid Laboratories, Inc.

K number K874718

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HIS 1987-12-08

KIMONO (CONDOMS)

Applicant Mayer Laboratories

K number K872799

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HIS 1987-12-08

BESTCON/SPERMICIDE

Applicant Europharmaceutical Corp.

K number K871451

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HIS 1987-11-20

SPERMICIDAL CONDOM

Applicant Royal American Industries, Inc.

K number K874464

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HIS 1987-11-20

LUBRICATED CONDOM

Applicant Royal American Industries, Inc.

K number K872504

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HIS 1987-11-05

SKINLESS-SKIN, PINK TINT (CONDOM)

Applicant Okamoto USA, Inc.

K number K872812

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HIS 1987-11-05

SKINLESS SKIN-HARMONY CONDOMS

Applicant Okamoto USA, Inc.

K number K872664

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HIS 1987-11-04

PREVENTETTE (CONDOM)

Applicant Reb Enterprises, Inc.

K number K872619

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HIS 1987-11-02

MAXIMUM, LATEX PROPHYLACTIC BRAND

Applicant Safe Product Supplies

K number K872005

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HIS 1987-10-20

PROPHYLACTIC (CONDOM)

Applicant Circle Rubber Corp.

K number K872736

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HIS 1987-10-20

ANGEL LATEX PROPHYLACTICS (CONDOMS)

Applicant Angel Intl. Trading Co., Inc.

K number K871948

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HIS 1987-10-20

CONDOM TAKASO RUBBER PRODUCTS SDN/BDH

Applicant Takaso Rubber C/O Interstate Supplier, Inc.

K number K871036

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HIS 1987-08-05

BESTCON/LUBRICATED CONDOMS

Applicant Europharmaceutical Corp.

K number K871470

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HIS 1987-07-21

KANGLE CONDOM

Applicant Lindley Company, Inc.

K number K871020

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HIS 1987-06-11

LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9

Applicant Ansell, Inc.

K number K871304

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HIS 1987-06-08

VIP'S PROPHYLACTICS, NATURAL, ANATOMIC & FEMINA

Applicant Professional Pharmacy West, Inc.

K number K871300

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HIS 1987-05-20

PROPHYLACTIC (CONDOM) MR. JOHNNY

Applicant Medelec Intl. Corp.

K number K865106

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HIS 1987-03-04

PERSONAL/DERBY CONDOMS

Applicant Razi Corp.

K number K862401

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HIS 1987-02-02

EXTRA STRONG CONDOM

Applicant Ansell, Inc.

K number K864400

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HIS 1986-12-30

PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME

Applicant Dongkuk Techco Rubber Industries

K number K864570

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HIS 1986-12-22

CHOICE

Applicant Select Sources, Inc.

K number K864482

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HIS 1986-12-03

SEMINAL FLUID COLLECTION KIT(TM)

Applicant Apex Technologies, Inc.

K number K864473

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HIS 1986-12-03

CHOICE CONDOM

Applicant Select Sources, Inc.

K number K863190

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HIS 1986-09-26

LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-40

Applicant Manexim Multicorp, Ltd.

K number K863707

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HIS 1986-09-26

LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-50

Applicant Manexim Multicorp, Ltd.

K number K863706

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HIS 1986-09-26

PROTEX, TAHITI CONDOM

Applicant U. C. Import & Co.

K number K860680

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HIS 1986-08-19

WORLDS BEST AND WORLDS BEST EXTRA SERIES (CONDOMS)

Applicant U. C. Import & Co.

K number K860909

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HIS 1986-04-11

PROPHYLACTIC (CONDOM)

Applicant Medelec Intl. Corp.

K number K854622

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HIS 1986-01-16

JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS

Applicant M/S Seohung Industrial Co., Ltd.

K number K854247

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HIS 1985-10-31

SAFE.N.SURE

Applicant Ashai Co. , Ltd.

K number K852620

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HIS 1985-05-23

LOVESAFE DOTTY CONDOM ONE DZ. CODOMS/BOX, DC-20

Applicant Manexim Multicorp, Ltd.

K number K851292

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HIS 1985-05-22

LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30

Applicant Manexim Multicorp, Ltd.

K number K851291

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HIS 1985-05-22

LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10

Applicant Manexim Multicorp, Ltd.

K number K851290

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HIS 1984-11-29

CASABLANCA

Applicant Arcon Corp.

K number K841600

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HIS 1984-09-21

WRINKLE CHAPEAU BLACKY

Applicant Circle Rubber Corp.

K number K842502

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HIS 1984-08-22

ULTRA SHAPE CONDOMS

Applicant Barnetts, Inc.

K number K833365

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HIS 1984-07-31

PROTEX CONTRACEPT PLUS W/SPERM-LUB

Applicant National Sanitary Laboratories, Inc.

K number K842185

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HIS 1984-02-04

STOPEX-CONDOMS-

Applicant Tropex Worldwide, Inc.

K number K834591

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HIS 1983-12-16

TROJAN PLUS II

Applicant Youngs Rubber Corp.

K number K833765

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HIS 1983-09-12

PROTEX CONTRACEPT PLUS W/SPERM-LUB

Applicant National Sanitary Laboratories, Inc.

K number K831816

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HIS 1983-03-31

PRIME

Applicant Ansell, Inc.

K number K830691

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HIS 1983-02-24

SEMINAL COLLECTION DEVICE

Applicant Health Development Corp.

K number K823937

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HIS 1982-11-03

MALE CONDOM

Applicant Schmid Laboratories, Inc.

K number K822088

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HIS 1982-09-30

NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT

Applicant Ansell, Inc.

K number K822792

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HIS 1982-05-28

WORLD'S BEST (CONTRACEPTIVE)

Applicant Rosen Kilde Stenhoj

K number K820564

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HIS 1982-03-05

CONDOM-MULTIPAL STYLES

Applicant Circle Rubber Corp.

K number K813172

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HIS 1980-03-20

UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA,

Applicant Kopharm, Inc.

K number K800518

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HIS 1980-01-16

CONCEPTROL/THIN PROPHYLACTICS

Applicant Ortho Pharmaceutical Corp.

K number K792634

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HIS 1979-10-04

NATURDOM

Applicant Juan C. Lucena

K number K790433

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HIS 1977-12-20

PROPHYLACTIC

Applicant Om Industries, Inc.

K number K772181

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HIS 1977-06-17

PROPHALACTICS

Applicant Jamar Health Products

K number K770412

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