510(k) · Cleared
Recalled · Class II · 2018Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health-Medical Products and Services · KGO Surgeon'S Gloves
Cleared on Apr 27, 2012 as substantially equivalent to K102500 (Cardinal Health, Inc., 2010) and 1 other predicate after a 133-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it. It has been recalled 8 times.
- Decided
- Apr 27, 2012
- Review
- 133 days
- Class
- Class I
- Product code
- KGO
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 2 generations to K013302 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK013302 Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested…Allegiance Healthcare Corp. · 2001
- 1 generation backK102500 Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health, Inc. · 2010
- This deviceK113707 Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health-Medical Products and Services · 2012
- Descendant · cites it directly · 1 of its ownK153316 Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with…Cardinal Health, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK161823 Powder Free Nitrile Surgical Glove, Sterile, Tested for use with…Wrp Asia Pacific Sdn. Bhd. · 2017
Most influential descendants
Showing 2 of 2 · See all- K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and…Cardinal Health, Inc. · 2016 · cites it directly1descendant
- K161823Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy DrugsWrp Asia Pacific Sdn. Bhd. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013302 | Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use… | Allegiance Healthcare Corp. | 2001 | — |
| −1 | K102500 | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating | Cardinal Health, Inc. | 2010 | — |
| 0 (this device) | K113707 | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating | Cardinal Health-Medical Products and Services | 2012 | — |
| +1 | K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile… | Cardinal Health, Inc. | 2016 | — |
| +2 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K102500 | Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingSummary page 1…1 CFR 878.4460 Product Code(s): 79KGO Legally marketed 1. Ourapreneq SMVT Sterile Polyisoprene Powder-Free Surgical Gloves, device(s) to which 510(k) K102500, (product code 79KG0). equivalence is claimed: 2. Duraprene Sterile Neoprene Powder-Free Surgical Gloves, 510(k)… | 2010 |
| * | K013302 | Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with…Summary page 1…(s) to which 510(k) K102500, (product code 79KG0). equivalence is claimed: 2. Duraprene Sterile Neoprene Powder-Free Surgical Gloves, 510(k) K013302, (product code 79KG0) Reason for 510(k) Addition of new indications for use: Tested for Use with Chemotherapy Submission:… | 2001 |
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 |
|---|---|---|---|
| K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and… | 2016 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 31, 2018 | Class II | Z-0631-2019 | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally… |
| Oct 31, 2018 | Class II | Z-0634-2019 | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally… |
| Oct 31, 2018 | Class II | Z-0632-2019 | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally… |
| Oct 31, 2018 | Class II | Z-0633-2019 | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally… |
| Oct 31, 2018 | Class II | Z-0635-2019 | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally… |
| Oct 31, 2018 | Class II | Z-0638-2019 | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally… |
| Oct 31, 2018 | Class II | Z-0636-2019 | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally… |
| Oct 31, 2018 | Class II | Z-0637-2019 | Labeling mix-ups | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally… |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K153316 (Cardinal Health, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K102500.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
These powder-free sterile light brown colored surgeon's gloves are 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: 1. Carmustine (BCNUJ) (3.3 mg/mi) — 0.2 2. Cisplastia, (1.0…
Read the full statement (150 words)
These powder-free sterile light brown colored surgeon's gloves are 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:
1. Carmustine (BCNUJ) (3.3 mg/mi) — 0.2
2. Cisplastia, (1.0 mg/mi) — >240
3. Cyclophosphamide (20 mg/nil) — >240
4. Doxorubicin HCl (2.0 mg/mi) — >240
5. Etoposide (20 mg/mi) — >240
6. Fluorouracil (50.0 mg/nil) — >240
7. Methotrexate (25 mg/mi) — >240
8. Paclitaxel (6.0 mg/mi) — >240
9. Thiotepa (10.0 mg/mi) — 82.2
10. Vincristine Sulfate (1.0 mg/nil) — >240
Please note that the following drug has extremely low permeation time of less than 30 minutes: Carmustine (BCNUL) (3.3 mg/mi) has a minimum breakthrough time of 0.20 minute.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113707 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113707: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113707
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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