510(k) · Cleared
ClearedCardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)
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 12, 2016 as substantially equivalent to K113707 (Cardinal Health-Medical Products and Services, 2012) after a 177-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- May 12, 2016
- Review
- 177 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013302 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK013302 Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested…Allegiance Healthcare Corp. · 2001
- 2 generations backK102500 Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health, Inc. · 2010
- 1 generation backK113707 Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health-Medical Products and Services · 2012 · Recalled
- This deviceK153316 Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with…Cardinal Health, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK161823 Powder Free Nitrile Surgical Glove, Sterile, Tested for use with…Wrp Asia Pacific Sdn. Bhd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K161823Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy DrugsWrp Asia Pacific Sdn. Bhd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013302 | Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use… | Allegiance Healthcare Corp. | 2001 | — |
| −2 | K102500 | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating | Cardinal Health, Inc. | 2010 | — |
| −1 | K113707 | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating | Cardinal Health-Medical Products and Services | 2012 | 8 |
| 0 (this device) | K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile… | Cardinal Health, Inc. | 2016 | — |
| +1 | K161823 | Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy… | Wrp Asia Pacific Sdn. Bhd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K113707 | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingSummary page 6…15 Page _2_ of 6_ Predicate Devices: K113707 - Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating Tested for Use with Chemotherapy Drugs… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161823 | Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs | 2017 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K161823 (Wrp Asia Pacific Sdn. Bhd., 2017) has gone furthest, with 0 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. 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
CAUTION: Testing showed an average breakthrough time of 60.1 minutes with Carmustine
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153316: Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153316
Report an extraction error
Are you the manufacturer?
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