510(k) · Cleared
ClearedHpi Brown Nitrile Sensi-Grip Surgical Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hpi, Inc. · KGO Surgeon'S Gloves
Cleared on Jun 17, 1992 after a 218-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jun 17, 1992
- Review
- 218 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK915086 Hpi Brown Nitrile Sensi-Grip Surgical GlovesHpi, Inc. · 1992
- Descendant · cites it directly · 2 of its ownK012166 Nitrile Powder-Free Medical Examination Glove (Brown)Best Manufacturing Company · 2001
- Descendant · 2 generations on · 0 of its ownK030075 Nitrile Powder-Free Medical Examination Glove (Blue) (Textured and…Best Manufacturing Company-Distribution Center · 2003
- Descendant · 2 generations on · 0 of its ownK022024 Nitrile Powder-Free Medical Examination Glove (Green)Best Manufacturing Company · 2002
- Descendant · cites it directly · 0 of its ownK970135 Nitrile GlovesSage Products, Inc. · 1997
Most influential descendants
Showing 4 of 4 · See all- K012166Nitrile Powder-Free Medical Examination Glove (Brown)Best Manufacturing Company · 2001 · cites it directly2descendants
- K030075Nitrile Powder-Free Medical Examination Glove (Blue) (Textured and Non-Textured)Best Manufacturing Company-Distribution Center · 2003 · 2 generations on0descendants
- K022024Nitrile Powder-Free Medical Examination Glove (Green)Best Manufacturing Company · 2002 · 2 generations on0descendants
- K970135Nitrile GlovesSage Products, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915086 | Hpi Brown Nitrile Sensi-Grip Surgical Gloves | Hpi, Inc. | 1992 | — |
| +1 | K012166 | Nitrile Powder-Free Medical Examination Glove (Brown) | Best Manufacturing Company | 2001 | — |
| +2 | K030075 | Nitrile Powder-Free Medical Examination Glove (Blue) (Textured and Non-Textured) | Best Manufacturing Company-Distribution Center | 2003 | — |
| +2 | K022024 | Nitrile Powder-Free Medical Examination Glove (Green) | Best Manufacturing Company | 2002 | — |
| +1 | K970135 | Nitrile Gloves | Sage Products, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K012166 (Best Manufacturing Company, 2001) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K915086 · printed Nov 4, 2026
Cite this page
510(k) Report. “K915086: Hpi Brown Nitrile Sensi-Grip Surgical Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K915086
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026