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 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K032124 | DUREX PLAY LUBRICANT | Ssl Americas, Inc. | 2004-01-16 | Traditional | PDF ↗ |
| K033541 | LONG LOVE CONDOM | Unidus Corp. | 2003-12-23 | Abbreviated | PDF ↗ |
| K033076 | LIFESTYLES LIQUID PERSONAL LUBRICANT | Ansell Healthcare, Inc. | 2003-12-19 | Traditional | PDF ↗ |
| K032909 | THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM | Thai Nippon Rubber Industry Co., Ltd. | 2003-12-16 | Abbreviated | PDF ↗ |
| K031007 | KWIKEZE MALE CONDOM APPLICATOR | Condax, LLC | 2003-11-14 | Abbreviated | PDF ↗ |
| K031369 | MERCATOR HEALTHCARE MALE LATEX CONDOM | Mercator Healthcare , Ltd. | 2003-10-31 | Abbreviated | PDF ↗ |
| K023333 | MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR | Pleasure Latex Products Sdn. Bhd. | 2003-06-23 | Abbreviated | PDF ↗ |
| K030176 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT | Suretex, Ltd. | 2003-04-17 | Abbreviated | PDF ↗ |
| K022614 | INVIGRA | Indus Medicare , Ltd. | 2003-04-08 | Abbreviated | PDF ↗ |
| K024324 | LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 | Global Protection Corp. | 2003-03-25 | Abbreviated | PDF ↗ |
| K023128 | NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM | Secure Scientific Sdn Bhd | 2003-01-22 | Abbreviated | PDF ↗ |
| K023405 | TROJAN MINT TINGLE BRAND LATEX CONDOMS | Armkel, LLC | 2002-12-16 | Abbreviated | PDF ↗ |
| K023175 | UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING) | Unidus Corp. | 2002-12-13 | Abbreviated | PDF ↗ |
| K023129 | UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK) | Unidus Corp. | 2002-12-13 | Abbreviated | PDF ↗ |
| K023176 | UNDUS MALE LATEX CONDOM (WITH FLAVORING) | Unidus Corp. | 2002-12-13 | Abbreviated | PDF ↗ |
| K023059 | UNIDUS MALE LATEX CONDOM | Unidus Corp. | 2002-12-12 | Abbreviated | PDF ↗ |
| K021125 | SENSUA! | Aac Consulting Group, Inc. | 2002-10-25 | Traditional | PDF ↗ |
| K021186 | CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG, | Condomi Erfert Prodoktionsgesellschaft Mbh | 2002-10-25 | Traditional | PDF ↗ |
| K021875 | MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM | Pleasure Latex Products Sdn. Bhd. | 2002-09-05 | Abbreviated | PDF ↗ |
| K020633 | NATURAL AND COLORED LATEX CONDOM WITH FLAVORS | Ls Rubber Sdn Bhd | 2002-05-15 | Abbreviated | PDF ↗ |
| K020272 | MALE LATEX CONDOM WITH RIBBED SURFACE | Pleasure Latex Products Sdn. Bhd. | 2002-04-26 | Abbreviated | PDF ↗ |
| K020659 | DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT | Ssl Americas, Inc. | 2002-03-29 | Special | PDF ↗ |
| K011363 | JOE LUBE CONDOM | Marketing Sales Concepts, Inc. (Msci) | 2002-03-25 | Abbreviated | PDF ↗ |
| K011378 | JOE LUB HELMET CONDOM | Marketing Sales Concepts, Inc. (Msci) | 2002-03-25 | Abbreviated | PDF ↗ |
| K020223 | INVIGRA | Indus Medicare , Ltd. | 2002-03-04 | Abbreviated | PDF ↗ |
| K013773 | SAFE | Ssn Medical Products Sdn. Bhd. | 2002-01-24 | Abbreviated | PDF ↗ |
| K013086 | WET LIGHT PERSONAL MOISTURIZER | Trigg Laboratories, Inc. | 2001-12-13 | Traditional | PDF ↗ |
| K012962 | DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM | Innolatex Sdn. Bhd | 2001-11-09 | Abbreviated | PDF ↗ |
| K012664 | ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT | Innolatex Sdn. Bhd | 2001-11-09 | Traditional | PDF ↗ |
| K012964 | 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM | Innolatex Sdn. Bhd | 2001-11-09 | Abbreviated | PDF ↗ |
| K012665 | ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT | Innolatex Sdn. Bhd | 2001-11-09 | Traditional | PDF ↗ |
| K012653 | MALE LATEX CONDOM | Qingdao Shuang Die Latex Production Co.,Ltd | 2001-09-21 | Abbreviated | PDF ↗ |
| K011253 | FLAVORED MALE LATEX CONDOM | Thai Nippon Rubber Industry Co., Ltd. | 2001-07-20 | Abbreviated | PDF ↗ |
| K010919 | MALE NATURAL RUBBER LATEX CONDOM | Innolatex Sdn. Bhd | 2001-06-15 | Abbreviated | PDF ↗ |
| K011480 | VIVA | Richter Rubber Technology Sdn. Bhd. | 2001-05-24 | Abbreviated | PDF ↗ |
| K010371 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT | Suretex, Ltd. | 2001-04-27 | Abbreviated | PDF ↗ |
| K010028 | SHEER THIN AROMAS RED LATEX CONDOM | Eagle Twe, Inc. | 2001-03-30 | Abbreviated | PDF ↗ |
| K004051 | SHEER THIN AROMAS YELLOW LATEX CONDOM | Eagle Twe, Inc. | 2001-03-29 | Traditional | PDF ↗ |
| K004016 | SHEER THIN AROMAS BLUE LATEX CONDOM | Eagle Twe, Inc. | 2001-03-27 | Abbreviated | PDF ↗ |
| K004036 | SHEER THIN AROMAS GREEN LATEX CONDOM | Eagle Twe, Inc. | 2001-03-27 | Abbreviated | PDF ↗ |
| K002393 | NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM | Innolatex Sdn. Bhd | 2000-12-19 | Abbreviated | PDF ↗ |
| K002571 | MULITPLE MALE LATX CONDOM | Pleasure Latex Products Sdn. Bhd. | 2000-11-16 | Abbreviated | PDF ↗ |
| K002060 | NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL | Dongkuk Techco Rubber Industries | 2000-09-07 | Abbreviated | PDF ↗ |
| K993389 | REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT | Remed Pharma | 2000-08-18 | Abbreviated | PDF ↗ |
| K993409 | REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT | Remed Pharma | 2000-08-18 | Abbreviated | PDF ↗ |
| K993403 | REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT | Remed Pharma | 2000-08-18 | Abbreviated | PDF ↗ |
| K994118 | OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS | Guilin Latex Factory | 2000-08-14 | Traditional | PDF ↗ |
| K001883 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM | Ansell Healthcare, Inc. | 2000-07-31 | Abbreviated | PDF ↗ |
| K001221 | MALE LATEX COMDOM WITH DOTTED SURFACE | Pleasure Latex Products Sdn. Bhd. | 2000-05-19 | Abbreviated | PDF ↗ |
| K001212 | TROJAN EXTRA LARGE LATEX CONDOM | Armkel, LLC | 2000-05-09 | Special | PDF ↗ |
| K000408 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM | Suretex Prophylactics , Ltd. | 2000-04-19 | Abbreviated | PDF ↗ |
| K000748 | TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT | Armkel, LLC | 2000-04-06 | Special | PDF ↗ |
| K994311 | MALE LATEX CONDOM WITH VANILLA FLAVOR | Pleasure Latex Products Sdn. Bhd. | 2000-03-21 | Abbreviated | PDF ↗ |
| K000038 | INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED | Indus Medicare , Ltd. | 2000-03-21 | Abbreviated | PDF ↗ |
| K000039 | INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED | Indus Medicare , Ltd. | 2000-03-21 | Abbreviated | PDF ↗ |
| K000040 | INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED | Indus Medicare , Ltd. | 2000-03-21 | Abbreviated | PDF ↗ |
| K994312 | MALE LATEX CONDOM 56MM | Pleasure Latex Products Sdn. Bhd. | 2000-03-21 | Abbreviated | PDF ↗ |
| K993737 | MIGHTY MAN (DYNAMIC LINKERS) | Medtech Products , Ltd. | 2000-03-20 | Abbreviated | PDF ↗ |
| K993735 | DOUBLE SPRINGERS | Medtech Products , Ltd. | 2000-03-20 | Abbreviated | PDF ↗ |
| K993733 | LOVE LOCKERS | Medtech Products , Ltd. | 2000-03-20 | Abbreviated | PDF ↗ |
| K993396 | REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT | Remed Pharma | 2000-02-15 | Abbreviated | PDF ↗ |
| K993408 | REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT | Remed Pharma | 2000-02-15 | Abbreviated | PDF ↗ |
| K993395 | REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT | Remed Pharma | 2000-02-15 | Abbreviated | PDF ↗ |
| K993404 | REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT | Remed Pharma | 2000-02-15 | Abbreviated | PDF ↗ |
| K993405 | REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT | Remed Pharma | 2000-02-15 | Abbreviated | PDF ↗ |
| K993390 | REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT | Remed Pharma | 2000-02-14 | Abbreviated | PDF ↗ |
| K993782 | SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9) | P.T. Vonix Latexindo Condom (Rubber) Mfg. | 2000-02-02 | Abbreviated | PDF ↗ |
| K993781 | SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED | P.T. Vonix Latexindo Condom (Rubber) Mfg. | 2000-02-02 | Abbreviated | PDF ↗ |
| K993779 | SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED | P.T. Vonix Latexindo Condom (Rubber) Mfg. | 2000-02-02 | Abbreviated | PDF ↗ |
| K994095 | LATEX CONDOM | Thai Nippon Rubber Industry Co., Ltd. | 2000-01-18 | Abbreviated | PDF ↗ |
| K993693 | INVIGRA | Indus Medicare , Ltd. | 1999-12-29 | Abbreviated | PDF ↗ |
| K993887 | ALATECH LATEX CONDOM | Alatech Healthcare, LLC | 1999-12-20 | Abbreviated | PDF ↗ |
| K992081 | VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL | Suretex Prophylactics (India) , Ltd. | 1999-08-19 | Abbreviated | PDF ↗ |
| K991892 | TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR | Line One Laboratories | 1999-08-19 | Traditional | PDF ↗ |
| K984392 | ANSELL CONDOMS | Ansell, Inc. | 1999-07-21 | Traditional | PDF ↗ |
| K990597 | SUMMER'S EVE LUBRICATING JELLY | C.B. Fleet Co., Inc. | 1999-07-19 | Traditional | PDF ↗ |
| K983518 | LIFESTYLES XTRA PLEASURE | Ansell, Inc. | 1999-07-06 | Traditional | PDF ↗ |
| K990925 | MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION) | Hardcover Products, Inc. | 1999-06-17 | Abbreviated | PDF ↗ |
| K991374 | INVIGRA | Indus Medicare , Ltd. | 1999-06-15 | Abbreviated | PDF ↗ |
| K991049 | CLIMAX | Medilatex Sdn. Bhd. | 1999-06-15 | Traditional | PDF ↗ |
| K983216 | CVS PERSONAL LUBRICANT | San-Mar Laboratories, Inc. | 1999-05-17 | Abbreviated | PDF ↗ |
| K980964 | MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS | Ls Rubber Sdn Bhd | 1999-03-12 | Traditional | PDF ↗ |
| K982380 | SURE | Pleasure Latex Products Sdn. Bhd. | 1999-02-26 | Traditional | PDF ↗ |
| K984488 | SHEER THIN | Twe Companies, Inc. | 1999-02-01 | Traditional | PDF ↗ |
| K984218 | OASIS | Glimex Corp. | 1998-12-17 | Abbreviated | PDF ↗ |
| K983320 | ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS | Suretex Prophylactics (India) , Ltd. | 1998-12-11 | Traditional | PDF ↗ |
| K983380 | DUREX LUBRAGEL LATEX CONDOM | London Intl., LLC | 1998-11-16 | Abbreviated | PDF ↗ |
| K982924 | DUREX SENSIDOM LATEX CONDOM | London Intl., LLC | 1998-11-16 | Traditional | PDF ↗ |
| K982673 | JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM | Key West Fragrance & Cosmetic | 1998-10-29 | Traditional | PDF ↗ |
| K980174 | DUREX COLORS AND SCENTS | London Intl., LLC | 1998-08-13 | Traditional | PDF ↗ |
| K980319 | DUREX ULTRA COMFORT | London Intl., LLC | 1998-05-20 | Traditional | PDF ↗ |
| K980204 | DUREX LATEX CONDOMS | London Intl., LLC | 1998-04-17 | Traditional | PDF ↗ |
| K980019 | HTL MALE CONDOM | Reddy Medtech Health Products , Ltd. | 1998-04-01 | Traditional | PDF ↗ |
| K971028 | WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED | Worlds-Best Gummivarefabrik A/S | 1998-03-02 | Traditional | PDF ↗ |
| K974323 | LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT | Reddy Medtech Health Products , Ltd. | 1998-02-10 | Traditional | PDF ↗ |
| K973780 | PERSONAL LUBRICATING LIQUID | Qualis, Inc. | 1997-11-26 | Traditional | PDF ↗ |
| K971793 | VERY PRIVATE INTIMATE MOISTURE | Brandwynne Corp. | 1997-11-24 | Traditional | PDF ↗ |
| K960552 | KNIGHT LIGHT NONLUBRICATED CONDOM | Global Protection Corp. | 1997-11-20 | Traditional | PDF ↗ |
| K971132 | ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS | G. Premjee (Usa), Inc. | 1997-09-03 | Traditional | PDF ↗ |
| K970581 | CLINIJEL | Hospicon Products | 1997-09-03 | Traditional | PDF ↗ |
Product code HIS · Class II · Obstetrics/Gynecology. Data: openFDA.