LTZ · Class II · 21 CFR 884.5310

FDA Product Code LTZ: Condom With Nonoxynol-9

Leading manufacturers include Custom Services Intl., Inc., London International U.S. Holdings, Inc. and Reddy Medtech Health Products , Ltd..

22
Total
22
Cleared
175d
Avg days
1990
Since

FDA 510(k) Cleared Condom With Nonoxynol-9 Devices (Product Code LTZ)

22 devices
1–22 of 22
Cleared Apr 27, 2004
CAUTION CONDOMS
K033163
Richard Van Haussen America, Inc.
Obstetrics & Gynecology · 172d
Cleared Jun 12, 2002
DOUBLE SPRINGERS NONOXNOL 9 CONDOM
K012969
Medtech Products , Ltd.
Obstetrics & Gynecology · 281d
Cleared Apr 27, 2001
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K010178
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 98d
Cleared Jan 28, 2001
CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX
K003375
Tecnilatex S.A.
Obstetrics & Gynecology · 90d
Cleared Aug 08, 2000
'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
K001978
Thai Nippon Rubber Industry Co., Ltd.
Obstetrics & Gynecology · 40d
Cleared Jun 08, 2000
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K001377
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 38d
Cleared Aug 02, 1999
INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
K992438
Indus Medicare , Ltd.
Obstetrics & Gynecology · 11d
Cleared Jun 18, 1999
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
K991047
Hardcover Products, Inc.
Obstetrics & Gynecology · 80d
Cleared May 17, 1999
MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
K990669
Dongkuk Techco Rubber Industries Sdn. Bhd.
Obstetrics & Gynecology · 76d
Cleared Mar 15, 1999
MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS
K981955
Ls Rubber Sdn Bhd
Obstetrics & Gynecology · 284d
Cleared Jun 19, 1998
ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
K981621
Suretex Prophylactics (India) , Ltd.
Obstetrics & Gynecology · 44d
Cleared Feb 09, 1998
LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT
K974324
Reddy Medtech Health Products , Ltd.
Obstetrics & Gynecology · 83d
Cleared Feb 09, 1998
LATEX CONDOMS (NATURAL COLOUR)
K974326
Reddy Medtech Health Products , Ltd.
Obstetrics & Gynecology · 83d
Cleared Oct 22, 1997
ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
K972836
G. Premjee (Usa), Inc.
Obstetrics & Gynecology · 83d
Cleared Sep 10, 1997
INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
K972429
Custom Services Intl., Inc.
Obstetrics & Gynecology · 75d
Cleared Sep 10, 1997
EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
K972430
Custom Services Intl., Inc.
Obstetrics & Gynecology · 75d
Cleared Jun 03, 1997
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY
K970791
Custom Services Intl., Inc.
Obstetrics & Gynecology · 91d
Cleared Jan 22, 1997
OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN
K963322
Custom Services Intl., Inc.
Obstetrics & Gynecology · 163d
Cleared Jul 22, 1996
LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS
K953813
London International U.S. Holdings, Inc.
Obstetrics & Gynecology · 353d
Cleared Jul 15, 1996
DUREX, RAMSES, SHEIK
K952415
London International U.S. Holdings, Inc.
Obstetrics & Gynecology · 419d
Cleared May 22, 1996
SPERMICIDAL LUBRICATED CONDOM
K931220
Monsys USA, Inc.
Obstetrics & Gynecology · 1169d
Cleared Oct 31, 1990
MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.
K904273
Carter Products
Obstetrics & Gynecology · 44d

About Product Code LTZ - Regulatory Context