510(k) · Cleared
Recalled · 2002Royale Brand Latex Condoms (Silicone)-Colored/Assorted Colors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G. Premjee (Usa), Inc. · HIS Condom
Cleared on Sep 3, 1997 as substantially equivalent to K910284 (Suretex, Ltd., 1991) and 1 other predicate after a 160-day review. Its family tree reaches back 1 generation to 1991. It has been recalled once.
- Decided
- Sep 3, 1997
- Review
- 160 days
- Class
- Class II
- Product code
- HIS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910284 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK910284 Condoms (Rubber Contraceptives)Suretex, Ltd. · 1991
- This deviceK971132 Royale Brand Latex Condoms (Silicone)-Colored/Assorted ColorsG. Premjee (Usa), Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910284 | Condoms (Rubber Contraceptives) | Suretex, Ltd. | 1991 | — |
| 0 (this device) | K971132 | Royale Brand Latex Condoms (Silicone)-Colored/Assorted Colors | G. Premjee (Usa), Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K910284 | Condoms (Rubber Contraceptives)Summary page 1…mary Prepared: March 26, 1997 Name of the Device: Royale ® Brand Latex Condoms - (Silicone)- Colored and Assorted Colors Predicate Device Information: Suretex Ltd., K#910284, Latex Rubber Condoms (Silicone) Sime Health Ltd., K#932983, Lubricated (Silicone) Latex Condoms (Colored) (Essential ™, Mi Vida™… | 1991 |
| * | K932983 | Colored Condoms (Essentials, MI Vida, Jiffi)Summary page 1…Brand Latex Condoms - (Silicone)- Colored and Assorted Colors Predicate Device Information: Suretex Ltd., K#910284, Latex Rubber Condoms (Silicone) Sime Health Ltd., K#932983, Lubricated (Silicone) Latex Condoms (Colored) (Essential ™, Mi Vida™ and Jiffi™). Device Description: A condom is a sheath whi… | 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.
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?
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/K971132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971132: Royale Brand Latex Condoms (Silicone)-Colored/Assorted Colors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971132
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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