510(k) · Cleared
ClearedInnerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's Choice/Jasmine/Drink/Naughty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Custom Services Intl., Inc. · LTZ Condom With Nonoxynol-9
Cleared on Jun 3, 1997 after a 91-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jun 3, 1997
- Review
- 91 days
- Class
- Class II
- Product code
- LTZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK970791 Innerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's…Custom Services Intl., Inc. · 1997
- Descendant · cites it directly · 0 of its ownK972430 Extrawear, Gentlemen's Choice W/Nonoxynol-9Custom Services Intl., Inc. · 1997
Most influential descendants
Showing 1 of 1 · See all- K972430Extrawear, Gentlemen's Choice W/Nonoxynol-9Custom Services Intl., Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970791 | Innerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's… | Custom Services Intl., Inc. | 1997 | — |
| +1 | K972430 | Extrawear, Gentlemen's Choice W/Nonoxynol-9 | Custom Services Intl., Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LTZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972430 | Extrawear, Gentlemen's Choice W/Nonoxynol-9 | 1997 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K972430 (Custom Services Intl., Inc., 1997) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LTZ devicesLTZ Condom With Nonoxynol-9: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LTZ
FDA has decided no LTZ device since 2007.
Median 510(k) review, days · LTZ
Too few LTZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LTZ
No recall names LTZ since 2007.
Adverse event reports per year · LTZ
1in 2014
MAUDE reports naming product code LTZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Extra strength lubricated rubrer male condom with Nonoxynol-9 for use as a contraceptive and prophylactic. Additional Statement: “Labdratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested.” Additional Statement: This dondom contains a latex condom and 8 spermicidal lubricant. The spermicide, Nonoxyno!-9, reduces the number of active sperm, thereby…
Read the full statement (114 words)
Extra strength lubricated rubrer male condom with Nonoxynol-9 for use as a contraceptive and prophylactic.
Additional Statement: “Labdratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested.”
Additional Statement: This dondom contains a latex condom and 8 spermicidal lubricant. The spermicide, Nonoxyno!-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if you lose your efection before withdrawal and some semen spill outside the condom. However the extent of the decreased risk has not been established. This condom should not be used sas a substitute er the combined use of a vaginal spermicide and a condom
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970791: Innerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's Choice/Jasmine/Drink/Naughty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970791
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026