FDA product code LTZ: Condom With Nonoxynol-9
LTZ is the FDA product code for condom with nonoxynol-9. It is a Class II device, regulated under 21 CFR 884.5310 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 22 510(k) submissions under LTZ, from 17 different applicants. The average 510(k) review took 175 days (median 83). FDA has posted 1 recall for LTZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Condom With Nonoxynol-9 |
| Device class | Class II |
| Regulation | 21 CFR 884.5310 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LTZ clearance
Top LTZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Custom Services Intl., Inc. | 4 | 1997-09-10 |
| Reddy Medtech Health Products , Ltd. | 2 | 1998-02-09 |
| London International U.S. Holdings, Inc. | 2 | 1996-07-22 |
| Richard Van Haussen America, Inc. | 1 | 2004-04-27 |
| Medtech Products , Ltd. | 1 | 2002-06-12 |
12 more applicants have LTZ clearances. See the full list in Caduvo.
Most recent LTZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033163 | Richard Van Haussen America, Inc. | CAUTION CONDOMS | 2004-04-27 | 172 |
| K012969 | Medtech Products , Ltd. | DOUBLE SPRINGERS NONOXNOL 9 CONDOM | 2002-06-12 | 281 |
| K010178 | Innolatex Sdn. Bhd | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | 2001-04-27 | 98 |
| K003375 | Tecnilatex S.A. | CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX | 2001-01-28 | 90 |
| K001978 | Thai Nippon Rubber Industry Co., Ltd. | 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 | 2000-08-08 | 40 |
Recalls for LTZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2002-11-25.
Frequently asked questions
What is FDA product code LTZ?
LTZ is the FDA product code for condom with nonoxynol-9. It is a Class II device, regulated under 21 CFR 884.5310 and reviewed by the Obstetrics and Gynecology panel.
What device class is LTZ?
Class II, regulation 21 CFR 884.5310. Typical premarket route: 510(k).
How long does a 510(k) take for product code LTZ?
Across 22 cleared submissions the average was 175 days from receipt to decision (median 83).
Which companies have the most LTZ clearances?
Custom Services Intl., Inc. (4); Reddy Medtech Health Products , Ltd. (2); London International U.S. Holdings, Inc. (2); Richard Van Haussen America, Inc. (1); Medtech Products , Ltd. (1).
Have LTZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2002-11-25.
Next steps
- Run an FDA pathway report with predicate devices for product code LTZ
- Run a recall and safety report across every LTZ manufacturer
- Watch product code LTZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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