510(k) · Cleared
ClearedGammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ansell Healthcare Products, LLC · KGO Surgeon'S Gloves
Cleared on May 23, 2019 as substantially equivalent to K111139 (Ansell Healthcare Products, Inc., 2011) after a 139-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- May 23, 2019
- Review
- 139 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013302 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK013302 Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested…Allegiance Healthcare Corp. · 2001
- 1 generation backK111139 Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical…Ansell Healthcare Products, Inc. · 2011 · Recalled
- This deviceK190018 Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for…Ansell Healthcare Products, LLC · 2019
- Descendant · cites it directly · 1 of its ownK221718 Polyisoprene Powder Free Surgical Glove Tested for Use with…Hartalega NGC Sdn. Bhd. · 2022
- Descendant · cites it directly · 0 of its ownK230079 Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs…Ansell Healthcare Products, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK230217 Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with…Grand Work Plastic Products Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K221718Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)Hartalega NGC Sdn. Bhd. · 2022 · cites it directly1descendant
- K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis…Ansell Healthcare Products, LLC · 2023 · cites it directly0descendants
- K230217Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd. · 2023 · 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 | K111139 | Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves… | Ansell Healthcare Products, Inc. | 2011 | 3 |
| 0 (this device) | K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with… | Ansell Healthcare Products, LLC | 2019 | — |
| +1 | K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs… | Hartalega NGC Sdn. Bhd. | 2022 | — |
| +1 | K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low… | Ansell Healthcare Products, LLC | 2023 | — |
| +2 | K230217 | Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with… | Grand Work Plastic Products Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K111139 | Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for USummary page 5…Classification Panel: 510k: General and Plastic Surgery K190018 Legally Marketed Predicate Device K111139 – Derma Prene lsotouch Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs. Device De… | 2011 |
What descends from it? (3)
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)
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 18 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K221718 (Hartalega NGC Sdn. Bhd., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K111139.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Test Chemotherapy drug & Concentration Average Breakthrough Detection…
Read the full statement (233 words)
Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
Test Chemotherapy drug & Concentration Average Breakthrough Detection Times(Minutes)
Blenoxane, 15 mg/ml >240
Busulfan, 6 mg/ml >240
Carmustine (BCNU), 3.3 mg/ml 10.2
Cisplatin , 1.0 mg/ml >240
Cyclophosphamide (Cytoxan), 20.0 mg/ml >240
Cytarabine , 100 mg/ml >240
Dacarbazine (DTIC), 10.0 mg/ml >240
Daunorubicin , 5 mg/ml >240
Docetaxel, 10.0 mg/ml >240
Doxorubicin Hydrochloride, 2.0 mg/ml >240
Etoposide (Toposar), 20.0 mg/ml >240
Fludarabine , 25 mg/ml >240
Fluorouracil , 50.0 mg/ml >240
Gemcitabine (Gemzar), 38 mg/ml >240
ldarubicin , 1 mg/ml >240
lfosfamide , 50.0 mg/ml >240
Irinotecan , 20.0 mg/ml >240
Mechlorethamine HCI, 1.0 mq/ml >240
Melphalan, 5 mg/ml >240
Methotrexate , 25 mg/ml, >240
Mitomycin C, 0.5 mg/ml >240
Mitoxantrone, 2.0mq/ml >240
Oxaliplatin , 2.0 mq/ml >240
Paclitaxel (Taxol), 6.0 mq/ml >240
Paraplatin , 10 mg/ml >240
Thiotepa , 10.0 mg/ml 11.5
Vincristine Sulfate, 1.0 mg/ml >240
Ellence 2 mg/ml >240
Rituximab 10 mg/ml >240
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 10.2 minutes and Thiotepa: 11.5 minutes.
Warning: Do not use with Carmustine and Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190018 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190018: Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190018
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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