510(k) · Cleared
ClearedSterile Latex Powder Free Surgical Gloves with Hydrogel Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Inc. · KGO Surgeon'S Gloves
Cleared on May 6, 2011 as substantially equivalent to K101811 (Cardinal Health, Inc., 2010) after a 25-day review. Its family tree reaches back 2 generations to 1999. 2 later devices descend from it.
- Decided
- May 6, 2011
- Review
- 25 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992171 (1999). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK992171 Coated Sterile Latex Powder-Free Surgical Gloves with Protein…Allegiance Healthcare Corp. · 1999
- 1 generation backK101811 Protegrity SMT Latex SurgicalglovesCardinal Health, Inc. · 2010
- This deviceK111015 Sterile Latex Powder Free Surgical Gloves with Hydrogel CoatingCardinal Health, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK151778 Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical…Cardinal Health 200, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK160875 Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical…Cardinal Health, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See all- K151778Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel…Cardinal Health 200, Inc. · 2016 · cites it directly1descendant
- K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with…Cardinal Health, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992171 | Coated Sterile Latex Powder-Free Surgical Gloves with Protein Content Labeling… | Allegiance Healthcare Corp. | 1999 | — |
| −1 | K101811 | Protegrity SMT Latex Surgicalgloves | Cardinal Health, Inc. | 2010 | — |
| 0 (this device) | K111015 | Sterile Latex Powder Free Surgical Gloves with Hydrogel Coating | Cardinal Health, Inc. | 2011 | — |
| +1 | K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with… | Cardinal Health 200, Inc. | 2016 | — |
| +2 | K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves… | Cardinal Health, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 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 |
|---|---|---|---|
| * | K101811 | Protegrity SMT Latex SurgicalglovesSummary page 1…h Nitrile Coating with Protein Content Label Claim of 50 ggldm2 or less previously cleared under 510(k) K101811 (product code KGO). Cardinal Health, Inc. Premartet Notification Submission - Traditional 51 0(k)… | 2010 |
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 |
|---|---|---|---|
| K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel… | 2016 | 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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K151778 (Cardinal Health 200, Inc., 2016) has gone furthest, with 1 descendant 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. 2011, this device’s year, is highlighted.
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 powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111015 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111015: Sterile Latex Powder Free Surgical Gloves with Hydrogel Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111015
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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