510(k) · Cleared
ClearedHpi Sensi-Shield Glove Kit
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 Mar 20, 1991 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 20, 1991
- Review
- 49 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK910383 Hpi Sensi-Shield Glove KitHpi, Inc. · 1991
- Descendant · cites it directly · 2 of its ownK960247 Ultra Care Powder Free Hypoallergenic Patient Examination GloveTillotson Healthcare Corp. · 1996
- Descendant · 2 generations on · 1 of its ownK982505 Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex…Tillotson Healthcare Corp. · 1999
- Descendant · 3 generations on · 0 of its ownK021007 Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex…Tillotson Healthcare Corp. · 2002
- Descendant · cites it directly · 0 of its ownK960225 Powder Free Plus Hypoallergenic (with Labeled Protein Content)…Tillotson Healthcare Corp. · 1996
Most influential descendants
Showing 4 of 4 · See all- K960247Ultra Care Powder Free Hypoallergenic Patient Examination GloveTillotson Healthcare Corp. · 1996 · cites it directly2descendants
- K982505Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient Examination GloveTillotson Healthcare Corp. · 1999 · 2 generations on1descendant
- K021007Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Glove Made From…Tillotson Healthcare Corp. · 2002 · 3 generations on0descendants
- K960225Powder Free Plus Hypoallergenic (with Labeled Protein Content) Patient Examination GlovesTillotson Healthcare Corp. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910383 | Hpi Sensi-Shield Glove Kit | Hpi, Inc. | 1991 | — |
| +1 | K960247 | Ultra Care Powder Free Hypoallergenic Patient Examination Glove | Tillotson Healthcare Corp. | 1996 | — |
| +2 | K982505 | Ultra Care Non-Sterile Powder Free (Green) Natural Rubber Latex Patient… | Tillotson Healthcare Corp. | 1999 | — |
| +3 | K021007 | Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Glove… | Tillotson Healthcare Corp. | 2002 | — |
| +1 | K960225 | Powder Free Plus Hypoallergenic (with Labeled Protein Content) Patient… | Tillotson Healthcare Corp. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 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 has not posted a summary or statement for it, 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, K960247 (Tillotson Healthcare Corp., 1996) 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/K910383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910383: Hpi Sensi-Shield Glove Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910383
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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