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 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K972428 | EXTRAWEAR, GENTLEMEN'S CHOICE | Custom Services Intl., Inc. | 1997-08-25 | Traditional | PDF ↗ |
| K972427 | INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK | Custom Services Intl., Inc. | 1997-08-20 | Traditional | PDF ↗ |
| K970767 | CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH | Custom Services Intl., Inc. | 1997-06-02 | Traditional | PDF ↗ |
| K970792 | INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE | Titan Condoms | 1997-06-02 | Traditional | PDF ↗ |
| K970633 | TUSTEX FLAVORED CONDOMS | Line One Laboratories | 1997-03-21 | Traditional | PDF ↗ |
| K964599 | TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR | Line One Laboratories | 1997-02-14 | Traditional | PDF ↗ |
| K964598 | TRUSTEX COLA FLAVORD CONDOM | Line One Laboratories | 1997-02-14 | Traditional | PDF ↗ |
| K964591 | TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR | Line One Laboratories | 1997-02-13 | Traditional | PDF ↗ |
| K955183 | SAFE KNIGHTS | L & N Corp. | 1997-02-11 | Traditional | PDF ↗ |
| K963321 | OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN | Custom Services Intl., Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K963319 | OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODIT,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN | Custom Services Intl., Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K963679 | LOVING SMARTER - SAFER SEX | Loving Smarter, Inc. | 1996-12-12 | Traditional | PDF ↗ |
| K960710 | CONDOM | Polar Latex , Ltd. | 1996-10-10 | Traditional | PDF ↗ |
| K946103 | TRUSTEX FLAVOR CONDON IN COLORS | Line One Laboratories & Trading Co. | 1996-07-15 | Traditional | PDF ↗ |
| K955648 | K-Y PERSONAL LUBRICANT | Ortho Pharmaceutical Corp. | 1996-06-21 | Traditional | PDF ↗ |
| K945145 | RIA LATEX CONDOM, NONOXYNOL-9 | Mbf Personal Care Sdn. Bhd. | 1996-02-21 | Traditional | PDF ↗ |
| K943880 | RIA LATEX CONDOM | Mbf Personal Care Sdn. Bhd. | 1996-02-13 | Traditional | PDF ↗ |
| K953583 | LUBRICATED CONDOM | Tactyl Technologies, Inc. | 1996-01-26 | Traditional | PDF ↗ |
| K946207 | CONQUEROR, RUMBA AND TEMPTATION | Frontline Latex Products Pvt. , Ltd. | 1996-01-24 | Traditional | PDF ↗ |
| K954791 | SEMINAL FLUID COLLECTION KIT II | Apex Medical Technologies, Inc. | 1996-01-05 | Traditional | PDF ↗ |
| K945930 | RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE | Line One Laboratories & Trading Co. | 1995-12-19 | Traditional | PDF ↗ |
| K940047 | SPERMICIDALLY LUBRICATED CONDOM | Ansell, Inc. | 1995-12-19 | Traditional | PDF ↗ |
| K944786 | RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK) | Line One Laboratories & Trading Co. | 1995-12-06 | Traditional | PDF ↗ |
| K941258 | LATEX CONDOM | Suretex, Ltd. | 1995-12-06 | Traditional | PDF ↗ |
| K952464 | PROBE PERSONAL LUBRICANT - CLASSIC | Davryan Laboratories, Inc. | 1995-11-22 | Traditional | PDF ↗ |
| K952465 | PROBE PERSONAL LUBRICANT - SILKY LIGHT | Davryan Laboratories, Inc. | 1995-11-22 | Traditional | PDF ↗ |
| K946374 | KIMONO MICROTHIN | Mayer Laboratories | 1995-11-08 | Traditional | PDF ↗ |
| K946376 | MAXX | Mayer Laboratories | 1995-09-22 | Traditional | PDF ↗ |
| K943064 | KIMONO (CONDOMS) | Mayer Laboratories | 1995-09-22 | Traditional | PDF ↗ |
| K945246 | PREVENTOR AND PROTECTOR LATEX CONDOMS | American Pharmaceutical Co., Inc. | 1995-09-07 | Traditional | PDF ↗ |
| K952393 | OKAMOTO CONDOM | Okamoto USA, Inc. | 1995-08-09 | Traditional | PDF ↗ |
| K943933 | SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM | Aladan Corp. | 1995-06-22 | Traditional | PDF ↗ |
| K932985 | AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI | Sime Health, Ltd. | 1995-06-16 | Traditional | PDF ↗ |
| K942858 | LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) | Suretex, Ltd. | 1995-05-18 | Traditional | PDF ↗ |
| K943883 | SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM | Aladan Corp. | 1995-04-14 | Traditional | PDF ↗ |
| K940046 | NON-LUBRICATED CONDOM | Ansell, Inc. | 1995-01-30 | Traditional | PDF ↗ |
| K940045 | CONDOM | Ansell, Inc. | 1995-01-30 | Traditional | PDF ↗ |
| K941831 | LUBRICATING JELLY | Barre-National, Inc. | 1995-01-03 | Traditional | PDF ↗ |
| K911431 | TACTYLON(TM) CONDOM | Tactyl Technologies, Inc. | 1994-12-27 | Traditional | PDF ↗ |
| K931077 | LATEX PROPHYLACTIC RUBBER CONTRACEPTIVE | J.K. Chemicals, Ltd. | 1994-09-14 | Traditional | PDF ↗ |
| K933153 | PENTHOUSE CONDOMS | Kuron Health Products Corp. | 1994-07-28 | Traditional | PDF ↗ |
| K932983 | COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI) | Sime Health, Ltd. | 1994-07-07 | Traditional | PDF ↗ |
| K932982 | SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI) | Sime Health, Ltd. | 1994-07-07 | Traditional | PDF ↗ |
| K932984 | UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI | Sime Health, Ltd. | 1994-07-07 | Traditional | PDF ↗ |
| K920514 | SPIRAL | Thornton Associates, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K922889 | CONDOOM SHELF LIFE -- MODIFICATIONS | Safetex Corp. | 1993-09-01 | Traditional | PDF ↗ |
| K912405 | LATEX PROPHYLACTIC (CONDOM) | Hevealactics Intl. Sdn Bhd | 1992-07-21 | Traditional | PDF ↗ |
| K913813 | JIFFI CONDOM (RUBBER) CONTRACEPTIVE | Sime Health, Ltd. | 1992-06-01 | Traditional | PDF ↗ |
| K912901 | TROJAN (TM-TBD) CONDOM | Carter Products | 1992-02-03 | Traditional | PDF ↗ |
| K910470 | CONDOMS, MOODS/SHARE & RAKSHAK | Hindustan Latex , Ltd. | 1991-12-18 | Traditional | PDF ↗ |
| K902772 | PLEASURE PLUS | Medimix Products, Inc. | 1991-08-14 | Traditional | PDF ↗ |
| K910284 | CONDOMS (RUBBER CONTRACEPTIVES) | Suretex, Ltd. | 1991-06-04 | Traditional | PDF ↗ |
| K910550 | CONDOMS/SAXON, GOLD CIRCLE COIN, EMBRACE & RAINBOW | Safetex Corp. | 1991-06-03 | Traditional | PDF ↗ |
| K910788 | CMI TENDER TOUCH VE #303TT AND 404TT | Challenge Mfg., Inc. | 1991-05-09 | Traditional | PDF ↗ |
| K910578 | MCLAUGHLIN LAPAROSCOPIC GRASPER | Marlo Surgical Technology | 1991-04-03 | Traditional | PDF ↗ |
| K902305 | TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM. | Armkel, LLC | 1991-03-29 | Traditional | PDF ↗ |
| K902324 | TP AND DESIGN, CONDOM | China National Medicines & Health Prod. I/E Corp. | 1991-03-29 | Traditional | PDF ↗ |
| K902936 | POLYURETHANE CONDOM | Apex Medical Technologies, Inc. | 1991-03-06 | Traditional | PDF ↗ |
| K904000 | TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR | Armkel, LLC | 1991-02-19 | Traditional | PDF ↗ |
| K905279 | CONDOM (RUBBER) CONTRACEPTIVE | Aladan Corp. | 1991-02-19 | Traditional | PDF ↗ |
| K905854 | CONDOMS | Barnetts, Inc. | 1991-02-15 | Traditional | PDF ↗ |
| K902907 | MAMBA CONDOM (RUBBER LATEX) | Rfsu | 1990-12-21 | Traditional | PDF ↗ |
| K896098 | GUARDIAN & JANITEX CONDOM/PROPHYLACTIC | Allied Rubber Industries Sdn. Bhd. | 1990-12-19 | Traditional | PDF ↗ |
| K904375 | KIMONO PLUS | Mayer Laboratories | 1990-11-26 | Traditional | PDF ↗ |
| K904453 | LABELLING MODIFICATION TO MAXX PLUS | Mayer Laboratories | 1990-11-23 | Traditional | PDF ↗ |
| K904840 | ORION PLUS/MODIFICATION | Mayer Laboratories | 1990-11-20 | Traditional | PDF ↗ |
| K902804 | EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT | Okamoto USA, Inc. | 1990-08-13 | Traditional | PDF ↗ |
| K902509 | SAXON RIBBED CONDOMS | Safetex Corp. | 1990-07-24 | Traditional | PDF ↗ |
| K897140 | THIN CONDOM RAMSES & SHEIK | Schmid Laboratories, Inc. | 1990-07-13 | Traditional | PDF ↗ |
| K896107 | RUBBER CONTRACEPTIVE | Banrub Sdn Bhd | 1990-06-29 | Traditional | PDF ↗ |
| K901202 | TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED | Carter Products | 1990-06-19 | Traditional | PDF ↗ |
| K900679 | MINT SCENTED CONDOMS | Schmid Laboratories, Inc. | 1990-06-07 | Traditional | PDF ↗ |
| K896987 | RUBBER CONDOM (NON-COLORED) | Hankook Latex Gongup Co., Ltd. | 1990-06-06 | Traditional | PDF ↗ |
| K896142 | RUBBER CONTRACEPTIVE (CONDOM) | Guangzhou No. 11 Rubber Factory | 1990-06-06 | Traditional | PDF ↗ |
| K901416 | CONDOM (RUBBER) CONTRACEPTIVE | Aladan Corp. | 1990-06-04 | Traditional | PDF ↗ |
| K901696 | LATEX CONDOMS - CODE NO. 403, 406, 421 & 1033 | Allercare/Nsl, Inc. | 1990-05-16 | Traditional | PDF ↗ |
| K901667 | LATEX CONDOMS - CODE NO. 401, 421 & 1002 | Allercare/Nsl, Inc. | 1990-05-16 | Traditional | PDF ↗ |
| K901669 | LATEX CONDOMS - CODE NO. 404, NO. 424 & NO. 1000 | Allercare/Nsl, Inc. | 1990-05-16 | Traditional | PDF ↗ |
| K897129 | CONDOMS (MULTIPLE BRANDS) | Sagami, Inc. | 1990-05-16 | Traditional | PDF ↗ |
| K901668 | LATEX CONDOMS - CODE NO. 402, CODE NO. 1028 | Allercare/Nsl, Inc. | 1990-05-16 | Traditional | PDF ↗ |
| K893039 | CONDOM (RUBBER) CONTRACEPTIVE | Chinteik Hygiene Products Co., Ltd. | 1990-05-04 | Traditional | PDF ↗ |
| K901192 | TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING) | Carter Products | 1990-04-16 | Traditional | PDF ↗ |
| K901198 | TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED | Carter Products | 1990-04-16 | Traditional | PDF ↗ |
| K901193 | TROJAN PLUS LUBRI. LATEX CONDOMS (MODIFIED LABEL) | Carter Products | 1990-04-16 | Traditional | PDF ↗ |
| K901196 | TROJAN FOR WOMEN LUBRI. CONDOMS MODIFIED LABELING | Carter Products | 1990-04-16 | Traditional | PDF ↗ |
| K901200 | TROJAN FOR WOMEN LATEX CONDOMS W/SPERMI. MODIFIED | Carter Products | 1990-04-16 | Traditional | PDF ↗ |
| K901199 | TROJAN-ENZ LATEX CONDOMS W/SPERMICIDAL MODIFIED | Carter Products | 1990-04-16 | Traditional | PDF ↗ |
| K901194 | TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL | Carter Products | 1990-04-16 | Traditional | PDF ↗ |
| K901190 | TROJANS LATEX CONDOMS (MODIFIED LABELING) | Carter Products | 1990-04-16 | Traditional | PDF ↗ |
| K901191 | TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING) | Carter Products | 1990-04-16 | Traditional | PDF ↗ |
| K901201 | TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED | Carter Products | 1990-04-16 | Traditional | PDF ↗ |
| K901195 | TROJAN RIBBED NATURALUBE LUBRI. CONDOMS MODIFIED | Carter Products | 1990-04-16 | Traditional | PDF ↗ |
| K901197 | TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL | Carter Products | 1990-04-16 | Traditional | PDF ↗ |
| K900359 | EMBRACE | Safetex Corp. | 1990-04-02 | Traditional | PDF ↗ |
| K900360 | SAXON ULTRA THIN | Safetex Corp. | 1990-04-02 | Traditional | PDF ↗ |
| K900357 | GOLD CIRCLE COIN | Safetex Corp. | 1990-04-02 | Traditional | PDF ↗ |
| K900358 | SAXON WET LUBE | Safetex Corp. | 1990-04-02 | Traditional | PDF ↗ |
| K901111 | NUDA (CURRENTLY CALLED ULTRA SENSITIVE) | Ansell, Inc. | 1990-03-27 | Traditional | PDF ↗ |
| K901112 | G.S.A. COLORED CONDOMS | Ansell, Inc. | 1990-03-27 | Traditional | PDF ↗ |
| K896623 | SAFECON CONDOMS - PINK COLOR | Quality Synthetics Intl, Inc. | 1990-02-16 | Traditional | PDF ↗ |
Product code HIS · Class II · Obstetrics/Gynecology. Data: openFDA.