510(k) · Cleared
Recalled · Class II · 2023Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for U
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ansell Healthcare Products, Inc. · KGO Surgeon'S Gloves
Cleared on Sep 2, 2011 as substantially equivalent to K013302 (Allegiance Healthcare Corp., 2001) after a 133-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 2, 2011
- Review
- 133 days
- Class
- Class I
- Product code
- KGO
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013302 (2001). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK013302 Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested…Allegiance Healthcare Corp. · 2001
- This deviceK111139 Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical…Ansell Healthcare Products, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK190018 Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for…Ansell Healthcare Products, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK221718 Polyisoprene Powder Free Surgical Glove Tested for Use with…Hartalega NGC Sdn. Bhd. · 2022
- Descendant · 2 generations on · 0 of its ownK230079 Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs…Ansell Healthcare Products, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK230217 Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with…Grand Work Plastic Products Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK150238 SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical…Medline Industries, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K190018Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy…Ansell Healthcare Products, LLC · 2019 · cites it directly3descendants
- K221718Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)Hartalega NGC Sdn. Bhd. · 2022 · 2 generations on1descendant
- K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis…Ansell Healthcare Products, LLC · 2023 · 2 generations on0descendants
- K230217Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd. · 2023 · 3 generations on0descendants
- K150238SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera…Medline Industries, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013302 | Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use… | Allegiance Healthcare Corp. | 2001 | — |
| 0 (this device) | K111139 | Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves… | Ansell Healthcare Products, Inc. | 2011 | — |
| +1 | K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with… | Ansell Healthcare Products, LLC | 2019 | — |
| +2 | K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs… | Hartalega NGC Sdn. Bhd. | 2022 | — |
| +2 | K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low… | Ansell Healthcare Products, LLC | 2023 | — |
| +3 | K230217 | Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with… | Grand Work Plastic Products Co., Ltd. | 2023 | — |
| +1 | K150238 | SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With… | Medline Industries, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K013302 | Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with…Summary page 1…ice Name: Cardinal Health Duraprene SMVT Powder-Free Synthetic Neoprene Surgical Gloves Tested for Use with Chemotherapy Drugs 510(k) Number: K013302 6.0 Identification of the Device: Derma PreneO lsotouch* Green Sterile Powder-Free Polyisoprene Surgical Gloves, Test… | 2001 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 3, 2023 | Class II | Z-0096-2024 | Process control | Some surgical glove sterile pouches were not completely sealed. |
| Aug 3, 2023 | Class II | Z-0097-2024 | Process control | Some surgical glove sterile pouches were not completely sealed. |
| Feb 19, 2022 | Class II | Z-0838-2022 | Other | Transport company failed to stop at the border for required FDA inspection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
Chemotherapy Drug Permeation
(average breakthrough detection time in minutes) (ASTM D6978-05)
*Carmustine 15.5
Cyclophosphamide >240
Doxorubicrn Hydrochloride >240
Etoposide (Toposar) >240
5-Fluorouracil >240
Paclitaxel (Taxol) >240
*ThioTEPA 15.5
Methotrexate >240
Vincristine Sulfate >240
Please note that Carmustine and ThioTEPA have an extremely low permeation time of 15.5 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111139: Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for U.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111139
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