510(k) · Cleared
ClearedExtrawear, Gentlemen's Choice
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Custom Services Intl., Inc. · HIS Condom
Cleared on Aug 25, 1997 as substantially equivalent to K970767 (Custom Services Intl., Inc., 1997) and 1 other predicate after a 59-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Aug 25, 1997
- Review
- 59 days
- Class
- Class II
- Product code
- HIS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K970767 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK970767 Condom (Rubber), Lubricated, Extra StrengthCustom Services Intl., Inc. · 1997
- This deviceK972428 Extrawear, Gentlemen's ChoiceCustom Services Intl., Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970767 | Condom (Rubber), Lubricated, Extra Strength | Custom Services Intl., Inc. | 1997 | — |
| 0 (this device) | K972428 | Extrawear, Gentlemen's Choice | Custom Services Intl., Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
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 HIS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HIS device
- #1 K262108 FAMA Male Latex Condoms – Aqueous Lubricant…score 13.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K970767 | Condom (Rubber), Lubricated, Extra StrengthSummary page 1…raceptive device, lubricated with silicone or nonlubricated, extra strength and colored. ExtraWear™, Gentlemen’s Choice™ Custom Services International Inc. Application K970767 (lubricated) and K970792 (nonlubricated) found to be substantially equivalent on June 2, 1997 (Type 1, Style 2, Class A) rubber… | 1997 |
| * | K970792 | Innerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's ChoiceSummary page 1…ted with silicone or nonlubricated, extra strength and colored. ExtraWear™, Gentlemen’s Choice™ Custom Services International Inc. Application K970767 (lubricated) and K970792 (nonlubricated) found to be substantially equivalent on June 2, 1997 (Type 1, Style 2, Class A) rubber contraceptive device, lu… | 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?
- None of the 2 ancestors has a recall.
How does its category compare?
All HIS devicesHIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIS
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIS
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIS
20in 2025
MAUDE reports naming product code HIS, 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 | 7 | 128 | 1 | 10 |
| 2008 | 3 | 157 | 0 | 11 |
| 2009 | 5 | 241 | 0 | 12 |
| 2010 | 1 | — | 0 | 22 |
| 2011 | 3 | 54 | 0 | 15 |
| 2012 | 7 | 106 | 1 | 10 |
| 2013 | 4 | 208 | 1 | 19 |
| 2014 | 7 | 242 | 0 | 16 |
| 2015 | 3 | 136 | 0 | 8 |
| 2016 | 5 | 115 | 0 | 5 |
| 2017 | 4 | 102 | 0 | 8 |
| 2018 | 2 | — | 0 | 11 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 4 | 240 | 0 | 12 |
| 2021 | 5 | 233 | 0 | 16 |
| 2022 | 10 | 112 | 0 | 18 |
| 2023 | 2 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 5 | 99 | 0 | 20 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Extra Strength lubricated rubber male condom 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.”
Extra strength nonlubricated rubber male condom 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.”
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/K972428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972428: Extrawear, Gentlemen's Choice.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972428
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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