510(k) · Cleared
ClearedGammex® PI Plus Glove-in-Glove™ System 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 26, 2023 as substantially equivalent to K190077 (Molnlycke Health Care Us, LLC, 2019) after a 602-day review. Its family tree reaches back 3 generations to 2008.
- Decided
- May 26, 2023
- Review
- 602 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K081180 (2008). 4 ancestors in all, the oldest K050184 (2005). No later device cites it as a predicate yet.
- Root · 3 generations backK081180 Skinsense Polyisoprene UndergloveMolnlycke Health Care Us, LLC · 2008
- 2 generations backK111413 Biogel (R) Indicator (R) UndergloveMolnlycke Health Care Us, LLC · 2012
- 1 generation backK190077 Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S…Molnlycke Health Care Us, LLC · 2019
- This deviceK213289 Gammex® PI Plus Glove-in-Glove™ System Tested For Use with…Ansell Healthcare Products, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K081180 | Skinsense Polyisoprene Underglove | Molnlycke Health Care Us, LLC | 2008 | — |
| −2 | K111413 | Biogel (R) Indicator (R) Underglove | Molnlycke Health Care Us, LLC | 2012 | — |
| −1 | K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator… | Molnlycke Health Care Us, LLC | 2019 | — |
| 0 (this device) | K213289 | Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveSummary page 5…ice Class: I Product Code: KGO, OPJ, LZC Classification Panel: General and Plastic Surgery Legally Marketed Predicate Device K190077 – Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove Legally Marketed Reference Device K1900… | 2019 |
| † | K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy… | 2019 |
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 15 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K190077.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove & outer-glove together. Please note that the following drugs have…
Read the full statement (250 words)
A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove & outer-glove together. Please note that the following drugs have extremely low permeation times: Carmustine: 35.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.
Test Chemotherapy drug & Concentration Average Breakthrough Detection Time (Minutes)
Bleomycin - 15.0 mg/ml >240
Busulfan - 6.0 mg/ml >240
Carboplatin - 10 mg/ml >240
Carmustine - 3.3 mg/ml 35.0
Cisplatin - 1.0 mg/ml >240
Cyclophosphamide - 20.0 mg/ml >240
Cytarabine HCl - 100.0 mg/ml >240
Dacarbazine - 10.0 mg/ml >240
Daunorubicin HCI - 5.0 mg/ml >240
Docetaxel - 10.0 mg/ml >240
Doxorubicin HCl 2.0 mg/ml >240
Epirubicin - 2.0 mg/ml >240
Etoposide - 20.0 mg/ml >240
Fludarabine - 25 mg/ml >240
Fluorouracil - 50.0 mg/ml >240
Gemcitabine - 38.0 mg/ml >240
Idarubicin - 1.0 mg/ml >240
Ifosfamide - 50.0 mg/ml >240
Irinotecan - 20.0 mg/ml >240
Mechlorethamine HCI - 1.0 mg/ml >240
Melphalan - 5.0 mg/ml >240
Methotrexate - 25.0 mg/ml >240
Mitomycin C - 0.5 mg/ml >240
Mitoxantrone - 2.0 mg/ml >240
Oxaliplatin - 2.0 mg/ml >240
Paclitaxel - 6.0 mg/ml >240
Rituximab - 10.0 mg/ml >240
Thiotepa - 10.0 mg/ml 67.0
Vincristine Sulfate - 1.0 mg/ml >240
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213289: Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213289
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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