ClearanceBrief
Panels › Obstetrics/Gynecology › Product code HIS · Class 2

Condom

Regulation 884.5300

3510(k)s in 12 months (402 all time)
1recalls in 12 months (7 all time)
4recalls that name a 510(k)
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Top companies in HIS

Company510(k)sRecalls
Carter Products150
Mayer Laboratories140
Okamoto USA, Inc.140
Ansell, Inc.120
Church & Dwight Co., Inc.120
Remed Pharma90
Schmid Laboratories, Inc.90
Innolatex Sdn. Bhd80
Pleasure Latex Products Sdn. Bhd.80
Suretex Limited80
Decided510(k)Device and applicantCode
Apr 19, 2000K000408LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
Suretex Prophylactics , Ltd.
HIS
Apr 6, 2000K000748TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
Armkel, LLC
HIS
Mar 21, 2000K994312MALE LATEX CONDOM 56MM
Pleasure Latex Products Sdn. Bhd., MY
HIS
Mar 21, 2000K994311MALE LATEX CONDOM WITH VANILLA FLAVOR
Pleasure Latex Products Sdn. Bhd., MY
HIS
Mar 21, 2000K000040INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED
Indus Medicare , Ltd., IN
HIS
Mar 21, 2000K000039INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED
Indus Medicare , Ltd., IN
HIS
Mar 21, 2000K000038INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED
Indus Medicare , Ltd., IN
HIS
Mar 20, 2000K993737MIGHTY MAN (DYNAMIC LINKERS)
Medtech Products , Ltd., IN
HIS
Mar 20, 2000K993735DOUBLE SPRINGERS
Medtech Products , Ltd., IN
HIS
Mar 20, 2000K993733LOVE LOCKERS
Medtech Products , Ltd., IN
HIS
Feb 15, 2000K993408REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT
Remed Pharma
HIS
Feb 15, 2000K993405REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT
Remed Pharma
HIS
Feb 15, 2000K993404REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT
Remed Pharma
HIS
Feb 15, 2000K993396REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT
Remed Pharma
HIS
Feb 15, 2000K993395REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT
Remed Pharma
HIS
Feb 14, 2000K993390REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT
Remed Pharma
HIS
Feb 2, 2000K993782SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9)
P.T. Vonix Latexindo Condom (Rubber) Mfg.
HIS
Feb 2, 2000K993781SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED
P.T. Vonix Latexindo Condom (Rubber) Mfg.
HIS
Feb 2, 2000K993779SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED
P.T. Vonix Latexindo Condom (Rubber) Mfg.
HIS
Jan 18, 2000K994095LATEX CONDOM
Thai Nippon Rubber Industry Co., Ltd.
HIS
Dec 29, 1999K993693INVIGRA
Indus Medicare , Ltd., IN
HIS
Dec 20, 1999K993887ALATECH LATEX CONDOM
Alatech Healthcare, LLC
HIS
Aug 19, 1999K992081VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL
Suretex Prophylactics (India) , Ltd.
HIS
Aug 19, 1999K991892TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
Line One Laboratories
HIS
Jul 21, 1999K984392ANSELL CONDOMS
Ansell, Inc.
HIS
Jul 19, 1999K990597SUMMER'S EVE LUBRICATING JELLY
C.B. Fleet Co., Inc.
HIS
Jul 6, 1999K983518LIFESTYLES XTRA PLEASURE
Ansell, Inc.
HIS
Jun 17, 1999K990925MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)
Hardcover Products, Inc., CA
HIS
Jun 15, 1999K991374INVIGRA
Indus Medicare , Ltd., IN
HIS
Jun 15, 1999K991049CLIMAX
Medilatex Sdn. Bhd., MY
HIS
May 17, 1999K983216CVS PERSONAL LUBRICANT
San-Mar Laboratories, Inc.
HIS
Mar 12, 1999K980964MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS
Ls Rubber Sdn Bhd
HIS
Feb 26, 1999K982380SURE
Pleasure Latex Products Sdn. Bhd., MY
HIS
Feb 1, 1999K984488SHEER THIN
Twe Companies, Inc.
HIS
Dec 17, 1998K984218OASIS
Glimex Corp.
HIS
Dec 11, 1998K983320ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
Suretex Prophylactics (India) , Ltd., IN
HIS
Nov 16, 1998K983380DUREX LUBRAGEL LATEX CONDOM
London Intl., LLC
HIS
Nov 16, 1998K982924DUREX SENSIDOM LATEX CONDOM
London Intl., LLC
HIS
Oct 29, 1998K982673JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM
Key West Fragrance & Cosmetic
HIS
Aug 13, 1998K980174DUREX COLORS AND SCENTS
London Intl., LLC
HIS
May 20, 1998K980319DUREX ULTRA COMFORT
London Intl., LLC
HIS
Apr 17, 1998K980204DUREX LATEX CONDOMS
London Intl., LLC
HIS
Apr 1, 1998K980019HTL MALE CONDOM
Reddy Medtech Health Products , Ltd., IN
HIS
Mar 2, 1998K971028WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED
Worlds-Best Gummivarefabrik A/S, DK
HIS
Feb 10, 1998K974323LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT
Reddy Medtech Health Products , Ltd.
HIS
Nov 26, 1997K973780PERSONAL LUBRICATING LIQUID
Qualis, Inc.
HIS
Nov 24, 1997K971793VERY PRIVATE INTIMATE MOISTURE
Brandwynne Corp.
HIS
Nov 20, 1997K960552KNIGHT LIGHT NONLUBRICATED CONDOM
Global Protection Corp.
HIS
Sep 3, 1997K971132ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS
G. Premjee (Usa), Inc.
HIS
Sep 3, 1997K970581CLINIJEL
Hospicon Products, GB
HIS

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