Atlas FDA

LTZ

22 FDA 510(k) clearances · Product code

83 daysmedian time to decision
353 days90th percentile
22clearances measured

FDA profile

Official device name
Condom With Nonoxynol-9
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5310
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
1996: 2 · 2001: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CAUTION CONDOMS (K033163)Richard Van Haussen America, Inc.2004-04-27
DOUBLE SPRINGERS NONOXNOL 9 CONDOM (K012969)Medtech Products , Ltd.2002-06-12
SPERMICIDAL LUBRICATED MALE LATEX CONDOM (K010178)Innolatex Sdn. Bhd2001-04-27
CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX (K003375)Tecnilatex S.A.2001-01-28
'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 (K001978)Thai Nippon Rubber Industry Co., Ltd.2000-08-08
SPERMICIDAL LUBRICATED MALE LATEX CONDOM (K001377)Pleasure Latex Products Sdn. Bhd.2000-06-08
INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) (K992438)Indus Medicare , Ltd.1999-08-02
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) (K991047)Hardcover Products, Inc.1999-06-18
MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) (K990669)Dongkuk Techco Rubber Industries Sdn. Bhd.1999-05-17
MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS (K981955)Ls Rubber Sdn Bhd1999-03-15
ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS (K981621)Suretex Prophylactics (India) , Ltd.1998-06-19
LATEX CONDOMS (NATURAL COLOUR) (K974326)Reddy Medtech Health Products , Ltd.1998-02-09
LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT (K974324)Reddy Medtech Health Products , Ltd.1998-02-09
ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS (K972836)G. Premjee (Usa), Inc.1997-10-22
INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 (K972429)Custom Services Intl., Inc.1997-09-10
EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 (K972430)Custom Services Intl., Inc.1997-09-10
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY (K970791)Custom Services Intl., Inc.1997-06-03
OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN (K963322)Custom Services Intl., Inc.1997-01-22
LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS (K953813)London International U.S. Holdings, Inc.1996-07-22
DUREX, RAMSES, SHEIK (K952415)London International U.S. Holdings, Inc.1996-07-15
SPERMICIDAL LUBRICATED CONDOM (K931220)Monsys USA, Inc.1996-05-22
MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB. (K904273)Carter Products1990-10-31

Track LTZ automatically

Every clearance here is in the API, with alerts when new ones post.