510(k) · Cleared
ClearedSempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Semperit Technische Produkte Gesellshaft · KGO Surgeon'S Gloves
Cleared on Jan 16, 2002 as substantially equivalent to K981096 (Semperit Technische Produkte Gesellshaft, 1998) after an 82-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Jan 16, 2002
- Review
- 82 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981096 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK981096 Sempermed Surgeons' Gloves - SupremeSemperit Technische Produkte Gesellshaft · 1998
- This deviceK013560 Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9Semperit Technische Produkte Gesellshaft · 2002
- Descendant · cites it directly · 1 of its ownK160781 Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons…Semperit Investments Asia Pte, Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK250313 Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color…Harps Europe Manufacturing GmbH · 2025
Most influential descendants
Showing 2 of 2 · See all- K160781Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons GlovesSemperit Investments Asia Pte, Ltd. · 2017 · cites it directly1descendant
- K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With…Harps Europe Manufacturing GmbH · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981096 | Sempermed Surgeons' Gloves - Supreme | Semperit Technische Produkte Gesellshaft | 1998 | — |
| 0 (this device) | K013560 | Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9 | Semperit Technische Produkte Gesellshaft | 2002 | — |
| +1 | K160781 | Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves | Semperit Investments Asia Pte, Ltd. | 2017 | — |
| +2 | K250313 | Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For… | Harps Europe Manufacturing GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2025 | 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 KGO? 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 KGO device
- #1 K192328 JR.MEDIK Latex Surgeon’s Gloves Powder Freescore 15.2 · 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? (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 |
|---|---|---|---|
| * | K981096 | Sempermed Surgeons' Gloves - SupremeSummary page 1…Classification Name: Surgeon’s glove 10-Substantial Equivalency is claimed against the following device: “Supreme” Sempermed® Latex Surgeon’s gloves, powder-free 51 0k #k981 096 (fefer to Appendix 2 for FDA notification letter r erme ® SUPREME isof the of this summary. THIS DEVICE (SUPREME) UNDERWENT A C… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160781 | Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves | 2017 | 1 |
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?
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGO
185in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGO
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGO
21in 2025
MAUDE reports naming product code KGO, 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 | 10 | 113 | 0 | 13 |
| 2008 | 2 | — | 0 | 8 |
| 2009 | 3 | 48 | 15 | 14 |
| 2010 | 6 | 87 | 1 | 16 |
| 2011 | 11 | 90 | 0 | 14 |
| 2012 | 7 | 133 | 0 | 14 |
| 2013 | 6 | 184 | 0 | 41 |
| 2014 | 7 | 257 | 0 | 28 |
| 2015 | 12 | 225 | 0 | 11 |
| 2016 | 9 | 218 | 2 | 15 |
| 2017 | 12 | 111 | 1 | 20 |
| 2018 | 7 | 194 | 8 | 15 |
| 2019 | 11 | 204 | 0 | 51 |
| 2020 | 15 | 117 | 0 | 15 |
| 2021 | 14 | 199 | 0 | 14 |
| 2022 | 6 | 127 | 2 | 10 |
| 2023 | 14 | 185 | 2 | 28 |
| 2024 | 2 | — | 0 | 18 |
| 2025 | 1 | — | 0 | 21 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by
operating room personnel to protect a surgical wound from contamination.
(21CFR 878.4460)
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/K013560 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013560: Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013560
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026