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 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K895640 | MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT | Armkel, LLC | 1990-01-23 | Traditional | PDF ↗ |
| K895091 | RIA (CONDOM) | La Technology Sdn. Bhd. | 1990-01-16 | Traditional | PDF ↗ |
| K896339 | MODIFIED LABELING ON OKAMOTO HARMONY CONDOM | Okamoto USA, Inc. | 1990-01-10 | Traditional | PDF ↗ |
| K893217 | LATEX PROPHYLACTIC/RUBBER CONTRACEPTIVE | Shinhen Corp. | 1990-01-10 | Traditional | PDF ↗ |
| K894533 | CONDOM (RUBBER LATEX) KILROY | Rfsu | 1989-12-18 | Traditional | PDF ↗ |
| K894534 | CONDOM (RUBBER LATEX) OKEIDO | Rfsu | 1989-12-14 | Traditional | PDF ↗ |
| K895028 | BIRDS'N BEES CONDOMS | Rfsu | 1989-12-14 | Traditional | PDF ↗ |
| K895894 | PROFIL CONDOM (RUBBER LATEX) | Rfsu | 1989-12-14 | Traditional | PDF ↗ |
| K895530 | STANDARD CONDOM | Mayer Laboratories | 1989-11-28 | Traditional | PDF ↗ |
| K884692 | THE SAFEGARD PERSONAL PROTECTION KIT | The Safegard Protection Corp. | 1989-09-12 | Traditional | PDF ↗ |
| K880819 | CONDOMS | Universal Trade, Inc. | 1989-08-11 | Traditional | PDF ↗ |
| K884925 | THE GREAT WALL CONDOM | Pacific Sales & Development Corp. | 1989-06-23 | Traditional | PDF ↗ |
| K890819 | HSV-CHECK(TM) TEST KIT | Diagnostic Technology, Inc. | 1989-06-20 | Traditional | PDF ↗ |
| K890407 | THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION | Circle Rubber Corp. | 1989-05-16 | Traditional | PDF ↗ |
| K884454 | SAFECON CONDOMS - RIBBED | Quality Synthetics Intl, Inc. | 1989-04-25 | Traditional | PDF ↗ |
| K890863 | TROJAN FOR WOMEN | Armkel, LLC | 1989-04-04 | Traditional | PDF ↗ |
| K884470 | KIMONO PLUS OTHERS (MULTIPLE) CONDOMS | Mayer Laboratories | 1989-03-31 | Traditional | PDF ↗ |
| K884469 | ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS | Mayer Laboratories | 1989-03-31 | Traditional | PDF ↗ |
| K884468 | SUPER MAXX OTHERS (MULTIPLE) CONDOMS | Mayer Laboratories | 1989-03-31 | Traditional | PDF ↗ |
| K883524 | SAFECON CONDOMS W/SPERMICIDAL LUBRICANT | Quality Synthetics Intl, Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K883409 | AEGIS(TM) CONDOMS | Green Cross Medical Supplies Corp. | 1989-03-13 | Traditional | PDF ↗ |
| K884402 | EXTRA STRENGTH SKIN LESS SKIN CONDOM | Okamoto USA, Inc. | 1989-03-10 | Traditional | PDF ↗ |
| K884399 | STANDARD LATEX CONDOM | Schmid Laboratories, Inc. | 1989-03-01 | Traditional | PDF ↗ |
| K871358 | SENSATIONS BRAND CONDOMS | Apex Medical Technologies, Inc. | 1989-03-01 | Traditional | PDF ↗ |
| K884401 | SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT | Okamoto USA, Inc. | 1989-01-12 | Traditional | PDF ↗ |
| K883413 | TROJAN EXTRA STRENGTH LUBRICATED | Carter Products | 1988-12-08 | Traditional | PDF ↗ |
| K882893 | CONDOMS (RAMSES, SHEIK AND KOROMEX) | Schmid Laboratories, Inc. | 1988-10-26 | Traditional | PDF ↗ |
| K883467 | THE SAXON SPERMICIDAL CONDOM | Circle Rubber Corp. | 1988-10-26 | Traditional | PDF ↗ |
| K882389 | KISS OF MINT(TM) NON-LUBRICATED CONDOM | Ansell, Inc. | 1988-10-20 | Traditional | PDF ↗ |
| K882009 | KING KONDOM (CONDOM) | King Kondom Products, Inc. | 1988-09-21 | Traditional | PDF ↗ |
| K881100 | CONDOM | Glnic Corp. | 1988-07-08 | Traditional | PDF ↗ |
| K881735 | CONDOM | Iris Medical Ent., Inc. | 1988-07-05 | Traditional | PDF ↗ |
| K874236 | APOLLO CONDOM | Apollo Enterprise, Ltd. Co. | 1988-07-01 | Traditional | PDF ↗ |
| K880919 | (CHOICE) ALSO (KONDUM) | Select Sources, Inc. | 1988-06-29 | Traditional | PDF ↗ |
| K880189 | NEW JELLIACOAT | K&G Import/Export Co. | 1988-06-27 | Traditional | PDF ↗ |
| K880820 | OKAMOTO CONDOMS SPERMICIDALLY LUBRICATED | Schmid Laboratories, Inc. | 1988-06-21 | Traditional | PDF ↗ |
| K880185 | DUET (CONDOMS) | American Laboratories, Inc. | 1988-06-17 | Traditional | PDF ↗ |
| K880463 | CONDOM (PROPHYLACTIC) | Health Technologies Intl. | 1988-06-13 | Traditional | PDF ↗ |
| K874921 | HEADFIRST (CONDOM) | Stual Products, Inc. | 1988-05-13 | Traditional | PDF ↗ |
| K875068 | AIDS SAFETY BELT | Aids Safety Belt, Inc. | 1988-05-10 | Traditional | PDF ↗ |
| K874791 | CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX) | Schmid Laboratories, Inc. | 1988-04-12 | Traditional | PDF ↗ |
| K871267 | BLAUSIEGEL TRANSPARENT CONDOMS | Ticosan, Inc. | 1988-04-12 | Traditional | PDF ↗ |
| K872356 | CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION) | Mayer Laboratories | 1988-04-06 | Traditional | PDF ↗ |
| K874399 | SAFECON CONDOMS | Quality Synthetics Intl, Inc. | 1988-04-06 | Traditional | PDF ↗ |
| K871744 | CONTATTO CONDOMS | Razi Corp. | 1988-03-09 | Traditional | PDF ↗ |
| K874383 | MENTOR PLUS (CONDOM) | Arcon Corp. | 1988-03-07 | Traditional | PDF ↗ |
| K880202 | OKAMOTO CONDOMS | Schmid Laboratories, Inc. | 1988-02-26 | Traditional | PDF ↗ |
| K875111 | RUBBER CONTRACEPTIVE, LATEX CONDOMS | Okamoto USA, Inc. | 1988-02-26 | Traditional | PDF ↗ |
| K874851 | XL-4 PAGODA (CONDOMS) | Mayer Laboratories | 1988-01-21 | Traditional | PDF ↗ |
| K874135 | CONDOM (PROPHYLACTIC) | Pactec, Inc. | 1988-01-19 | Traditional | PDF ↗ |
| K872861 | LOVIEL CONDOM | Lloviel Marketing Corp. | 1987-12-11 | Traditional | PDF ↗ |
| K874718 | STANDARD LATEX CONDOMS (RAMSES, SHEIK AND KOROMEX) | Schmid Laboratories, Inc. | 1987-12-08 | Traditional | PDF ↗ |
| K871451 | BESTCON/SPERMICIDE | Europharmaceutical Corp. | 1987-12-08 | Traditional | PDF ↗ |
| K872799 | KIMONO (CONDOMS) | Mayer Laboratories | 1987-12-08 | Traditional | PDF ↗ |
| K874464 | SPERMICIDAL CONDOM | Royal American Industries, Inc. | 1987-11-20 | Traditional | PDF ↗ |
| K872504 | LUBRICATED CONDOM | Royal American Industries, Inc. | 1987-11-20 | Traditional | PDF ↗ |
| K872664 | SKINLESS SKIN-HARMONY CONDOMS | Okamoto USA, Inc. | 1987-11-05 | Traditional | PDF ↗ |
| K872812 | SKINLESS-SKIN, PINK TINT (CONDOM) | Okamoto USA, Inc. | 1987-11-05 | Traditional | PDF ↗ |
| K872619 | PREVENTETTE (CONDOM) | Reb Enterprises, Inc. | 1987-11-04 | Traditional | PDF ↗ |
| K872005 | MAXIMUM, LATEX PROPHYLACTIC BRAND | Safe Product Supplies | 1987-11-02 | Traditional | PDF ↗ |
| K872736 | PROPHYLACTIC (CONDOM) | Circle Rubber Corp. | 1987-10-20 | Traditional | PDF ↗ |
| K871948 | ANGEL LATEX PROPHYLACTICS (CONDOMS) | Angel Intl. Trading Co., Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K871036 | CONDOM TAKASO RUBBER PRODUCTS SDN/BDH | Takaso Rubber C/O Interstate Supplier, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K871470 | BESTCON/LUBRICATED CONDOMS | Europharmaceutical Corp. | 1987-08-05 | Traditional | PDF ↗ |
| K871020 | KANGLE CONDOM | Lindley Company, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K871304 | LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9 | Ansell, Inc. | 1987-06-11 | Traditional | PDF ↗ |
| K871300 | VIP'S PROPHYLACTICS, NATURAL, ANATOMIC & FEMINA | Professional Pharmacy West, Inc. | 1987-06-08 | Traditional | PDF ↗ |
| K865106 | PROPHYLACTIC (CONDOM) MR. JOHNNY | Medelec Intl. Corp. | 1987-05-20 | Traditional | PDF ↗ |
| K862401 | PERSONAL/DERBY CONDOMS | Razi Corp. | 1987-03-04 | Traditional | PDF ↗ |
| K864400 | EXTRA STRONG CONDOM | Ansell, Inc. | 1987-02-02 | Traditional | PDF ↗ |
| K864570 | PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME | Dongkuk Techco Rubber Industries | 1986-12-30 | Traditional | PDF ↗ |
| K864482 | CHOICE | Select Sources, Inc. | 1986-12-22 | Traditional | PDF ↗ |
| K864473 | SEMINAL FLUID COLLECTION KIT(TM) | Apex Technologies, Inc. | 1986-12-03 | Traditional | PDF ↗ |
| K863190 | CHOICE CONDOM | Select Sources, Inc. | 1986-12-03 | Traditional | PDF ↗ |
| K860680 | PROTEX, TAHITI CONDOM | U. C. Import & Co. | 1986-09-26 | Traditional | PDF ↗ |
| K863707 | LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-40 | Manexim Multicorp, Ltd. | 1986-09-26 | Traditional | PDF ↗ |
| K863706 | LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-50 | Manexim Multicorp, Ltd. | 1986-09-26 | Traditional | PDF ↗ |
| K860909 | WORLDS BEST AND WORLDS BEST EXTRA SERIES (CONDOMS) | U. C. Import & Co. | 1986-08-19 | Traditional | PDF ↗ |
| K854622 | PROPHYLACTIC (CONDOM) | Medelec Intl. Corp. | 1986-04-11 | Traditional | PDF ↗ |
| K854247 | JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS | M/S Seohung Industrial Co., Ltd. | 1986-01-16 | Traditional | PDF ↗ |
| K852620 | SAFE.N.SURE | Ashai Co. , Ltd. | 1985-10-31 | Traditional | PDF ↗ |
| K851292 | LOVESAFE DOTTY CONDOM ONE DZ. CODOMS/BOX, DC-20 | Manexim Multicorp, Ltd. | 1985-05-23 | Traditional | PDF ↗ |
| K851291 | LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30 | Manexim Multicorp, Ltd. | 1985-05-22 | Traditional | PDF ↗ |
| K851290 | LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10 | Manexim Multicorp, Ltd. | 1985-05-22 | Traditional | PDF ↗ |
| K841600 | CASABLANCA | Arcon Corp. | 1984-11-29 | Traditional | PDF ↗ |
| K842502 | WRINKLE CHAPEAU BLACKY | Circle Rubber Corp. | 1984-09-21 | Traditional | PDF ↗ |
| K833365 | ULTRA SHAPE CONDOMS | Barnetts, Inc. | 1984-08-22 | Traditional | PDF ↗ |
| K842185 | PROTEX CONTRACEPT PLUS W/SPERM-LUB | National Sanitary Laboratories, Inc. | 1984-07-31 | Traditional | PDF ↗ |
| K834591 | STOPEX-CONDOMS- | Tropex Worldwide, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K833765 | TROJAN PLUS II | Youngs Rubber Corp. | 1983-12-16 | Traditional | PDF ↗ |
| K831816 | PROTEX CONTRACEPT PLUS W/SPERM-LUB | National Sanitary Laboratories, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K830691 | PRIME | Ansell, Inc. | 1983-03-31 | Traditional | PDF ↗ |
| K823937 | SEMINAL COLLECTION DEVICE | Health Development Corp. | 1983-02-24 | Traditional | PDF ↗ |
| K822088 | MALE CONDOM | Schmid Laboratories, Inc. | 1982-11-03 | Traditional | PDF ↗ |
| K822792 | NUDA-PLUS CONDOM W/SPERMICIDAL LUBRICANT | Ansell, Inc. | 1982-09-30 | Traditional | PDF ↗ |
| K820564 | WORLD'S BEST (CONTRACEPTIVE) | Rosen Kilde Stenhoj | 1982-05-28 | Traditional | PDF ↗ |
| K813172 | CONDOM-MULTIPAL STYLES | Circle Rubber Corp. | 1982-03-05 | Traditional | PDF ↗ |
| K800518 | UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA, | Kopharm, Inc. | 1980-03-20 | Traditional | PDF ↗ |
| K792634 | CONCEPTROL/THIN PROPHYLACTICS | Ortho Pharmaceutical Corp. | 1980-01-16 | Traditional | PDF ↗ |
| K790433 | NATURDOM | Juan C. Lucena | 1979-10-04 | Traditional | PDF ↗ |
Product code HIS · Class II · Obstetrics/Gynecology. Data: openFDA.