510(k) · Cleared
Recalled · 2002Royale of Latex Condoms - Spermicidal Lubricant - Colored or Assorted Colors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suretex Prophylactics (India), Ltd. · LTZ Condom With Nonoxynol-9
Cleared on Jun 19, 1998 as substantially equivalent to K942858 (Suretex, Ltd., 1995) and 1 other predicate after a 44-day review. Its family tree reaches back 1 generation to 1994. It has been recalled once.
- Decided
- Jun 19, 1998
- Review
- 44 days
- Class
- Class II
- Product code
- LTZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932982 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK932982 Spermicidal Lubric. Condoms (Essentials, MI Vida, Jiffi)Sime Health, Ltd. · 1994
- This deviceK981621 Royale of Latex Condoms - Spermicidal Lubricant - Colored or…Suretex Prophylactics (India), Ltd. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932982 | Spermicidal Lubric. Condoms (Essentials, MI Vida, Jiffi) | Sime Health, Ltd. | 1994 | — |
| 0 (this device) | K981621 | Royale of Latex Condoms - Spermicidal Lubricant - Colored or Assorted Colors | Suretex Prophylactics (India), Ltd. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 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? (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 |
|---|---|---|---|
| * | K942858 | Latex Condoms W/Spermicidal Lubricant (Nonoxynol-9)Summary page 1…e: Latex Condoms -Spermicidat Lubricant - Natural and assorted colors in Royale brand or in any other private label. 3. Predicate Device Information: Suretex Ltd., K# 942858A, Latex condoms with Spermicidal Lubricant. Sime Health Ltd., K# 932982, Spermicidal lubricated condoms (Essential, Mi Vida and J… | 1995 |
| * | K932982 | Spermicidal Lubric. Condoms (Essentials, MI Vida, Jiffi)Summary page 1…n Royale brand or in any other private label. 3. Predicate Device Information: Suretex Ltd., K# 942858A, Latex condoms with Spermicidal Lubricant. Sime Health Ltd., K# 932982, Spermicidal lubricated condoms (Essential, Mi Vida and Jiffi). 4. Device Description A condom with a spermicidal lubricant is… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2002 | Not classified | Z-0402-03 | Other | The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K942858.
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?
The intended use of this condom is for contraception and prophylactic purposes
(preventing transmission of venereal disease).
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/K981621 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981621: Royale of Latex Condoms - Spermicidal Lubricant - Colored or Assorted Colors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981621
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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