510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LTZClass II

Condom With Nonoxynol-9

21 CFR 884.5310 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

LTZ is the FDA product code for Condom With Nonoxynol-9, a class II device type, regulated under 21 CFR 884.5310. As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LTZ
Device name
Condom With Nonoxynol-9
Regulation
21 CFR 884.5310
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
22
Ingested recalls
1

Clearances, product code LTZ

By decision year
22 clearances under product code LTZ with a decision year between 1990 and 2004, 1997 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code LTZ by decision year
YearClearances
19901
19963
19975
19983
19994
20002
20012
20021
20041

Applicants with the most clearances

Product code LTZ
Applicants holding the most 510(k) clearances under product code LTZ
ApplicantClearances
Custom Services Intl., Inc.4
London International U.S. Holdings, Inc.2
Reddy Medtech Health Products, Ltd.2
Carter Products1
Dongkuk Techco Rubber Industries Sdn. Bhd.1
G. Premjee (USA), Inc.1
Hardcover Products, Inc.1
Indus Medicare, Ltd.1
Innolatex Sdn. Bhd1
Ls Rubber Sdn Bhd1

Companies listing this code with FDA

Companies whose registered establishments list this code