LTZ — Condom With Nonoxynol-9 Class II

FDA Device Classification

Classification Details

Product Code
LTZ
Device Class
Class II
Regulation Number
884.5310
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K033163richard van haussen americaCAUTION CONDOMSApril 27, 2004
K012969medtech productsDOUBLE SPRINGERS NONOXNOL 9 CONDOMJune 12, 2002
K010178innolatex sdn. bhdSPERMICIDAL LUBRICATED MALE LATEX CONDOMApril 27, 2001
K003375tecnilatexCONTROL MALE CONDOMS OF NATURAL RUBBER LATEXJanuary 28, 2001
K001978thai nippon rubber industry co'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9August 8, 2000
K001377pleasure latex products sdn. bhdSPERMICIDAL LUBRICATED MALE LATEX CONDOMJune 8, 2000
K992438indus medicareINVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)August 2, 1999
K991047hardcover productsHARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)June 18, 1999
K990669dongkuk techco rubber industries sdn. bhdMULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)May 17, 1999
K981955ls rubberMAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMSMarch 15, 1999
K981621suretex prophylactics (india)ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORSJune 19, 1998
K974326reddy medtech health productsLATEX CONDOMS (NATURAL COLOUR)February 9, 1998
K974324reddy medtech health productsLATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANTFebruary 9, 1998
K972836g. premjee (usa)ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORSOctober 22, 1997
K972429custom services intlINNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9September 10, 1997
K972430custom services intlEXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9September 10, 1997
K970791custom services intlINNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHJune 3, 1997
K963322custom services intlOLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPJanuary 22, 1997
K953813london international u.s. holdingsLONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMSJuly 22, 1996
K952415london international u.s. holdingsDUREX, RAMSES, SHEIKJuly 15, 1996