510(k) · Cleared
ClearedCardinal Health Sterile Polyisoprene Powder-Free Orthopedic 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 Jul 11, 2016 as substantially equivalent to K092304 (Cardinal Health, Inc., 2009) and 1 other predicate after a 103-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Jul 11, 2016
- Review
- 103 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K992171 (1999). 8 ancestors in all, the oldest K903987 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK992171 Coated Sterile Latex Powder-Free Surgical Gloves with Protein…Allegiance Healthcare Corp. · 1999
- 3 generations backK101811 Protegrity SMT Latex SurgicalglovesCardinal Health, Inc. · 2010
- 2 generations backK111015 Sterile Latex Powder Free Surgical Gloves with Hydrogel CoatingCardinal Health, Inc. · 2011
- 1 generation backK151778 Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical…Cardinal Health 200, Inc. · 2016
- This deviceK160875 Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical…Cardinal Health, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K992171 | Coated Sterile Latex Powder-Free Surgical Gloves with Protein Content Labeling… | Allegiance Healthcare Corp. | 1999 | — |
| −3 | K101811 | Protegrity SMT Latex Surgicalgloves | Cardinal Health, Inc. | 2010 | — |
| −2 | 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 | — |
| 0 (this device) | K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves… | Cardinal Health, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 2 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K092304 | Esteem Ortho Polyisoprene Powder-Free Surgical GlovesSummary page 5…(K) SUMMARY (CONT’D) Predicate Devices: 1) Esteem Ortho Polyisoprene Powder-Free Surgical Sterile Gloves previously cleared under K092304 on September 15, 2009 2) Sterile Latex Powder-Free Surgical Orthopedic… | 2009 |
| * | K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel…Summary page 5…2009 2) Sterile Latex Powder-Free Surgical Orthopedic Gloves with Hydrogel Coating cleared under K151778 on March 24, 2016 Reason for 510(k) Submission: New device Device Description: The proposed device is a d… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 synthetic 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/K160875 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160875: Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160875
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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