510(k) · Cleared
ClearedExtrawear, Gentlemen's Choice W/Nonoxynol-9
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 Sep 10, 1997 as substantially equivalent to K970791 (Custom Services Intl., Inc., 1997) after a 75-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Sep 10, 1997
- Review
- 75 days
- Class
- Class II
- Product code
- LTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970791 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970791 Innerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's…Custom Services Intl., Inc. · 1997
- This deviceK972430 Extrawear, Gentlemen's Choice W/Nonoxynol-9Custom Services Intl., Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970791 | Innerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's… | Custom Services Intl., Inc. | 1997 | — |
| 0 (this device) | K972430 | Extrawear, Gentlemen's Choice W/Nonoxynol-9 | Custom Services Intl., Inc. | 1997 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970791 | Innerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's Choice/Jasmine/Drink/NaughtySummary page 1…ent Nonoxynol-9 spermicide, extra strength and colored. Trade Names: ExtraWear™,_ Gentlemen’s Choice™ Equivalent Device: Custom Services International Inc. Application K970791 found to be substantially equivalent on June _, 1997 (Type 1, Style 2, Class A) rubber contraceptive device, lubricated with Nono… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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 rubber male condom with Nonoxynol-9 for use as a contraceptive and prophylactic. Additional Statement: “Laboratory 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 condom contains a latex condom and a spermicidal lubricant. The spermicide, Nonoxynol-9, reduces the number of active sperm, thereby…
Read the full statement (114 words)
Extra strength lubricated rubber male condom with Nonoxynol-9 for use as a contraceptive and prophylactic.
Additional Statement: “Laboratory 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 condom contains a latex condom and a spermicidal lubricant. The spermicide, Nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if you lose your erection 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 as a substitute for the combined use of a vaginal spermicide and a condom
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972430: Extrawear, Gentlemen's Choice W/Nonoxynol-9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972430
Report an extraction error
Are you the manufacturer?
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