510(k) · Cleared
ClearedGammex PI Hybrid 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 Mar 22, 2019 as substantially equivalent to K151694 (Ansell Healthcare Products, LLC, 2016) after a 150-day review. Its family tree reaches back 2 generations to 2007. 1 later device descends from it.
- Decided
- Mar 22, 2019
- Review
- 150 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071746 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK071746 Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic…Ansell Healthcare Products, LLC · 2007
- 1 generation backK151694 Gammex PI Hybrid Surgical GlovesAnsell Healthcare Products, LLC · 2016
- This deviceK182948 Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy…Ansell Healthcare Products, LLC · 2019
- Descendant · cites it directly · 0 of its ownK231902 GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro…Ansell Healthcare · 2023
Most influential descendants
Showing 1 of 1 · See all- K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid…Ansell Healthcare · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071746 | Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene… | Ansell Healthcare Products, LLC | 2007 | — |
| −1 | K151694 | Gammex PI Hybrid Surgical Gloves | Ansell Healthcare Products, LLC | 2016 | — |
| 0 (this device) | K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | 2019 | — |
| +1 | K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX… | Ansell Healthcare | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K151694 | Gammex PI Hybrid Surgical GlovesSummary page 5…KGO Classification Panel: General and Plastic Surgery 510k: K182948 Legally Marketed Predicate Device K151694 – Gammex PI Hybrid Surgical Gloves Device Description Gammex PI Hybrid Surgical Gloves are sterile and disposable device… | 2016 |
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 |
|---|---|---|---|
| K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid… | 2023 | 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 12 years and passes through 1 company; a new generation was cleared every 8.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231902 (Ansell Healthcare, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K151694.
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 PI Hybrid Surgical Gloves 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 Minimum Breakthrough Detection Time in Minutes Bleomycin sulfate (15.0 mg/ml)…
Read the full statement (183 words)
Gammex PI Hybrid Surgical Gloves 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 Minimum Breakthrough Detection Time in Minutes
Bleomycin sulfate (15.0 mg/ml) >240
Busulfan (6.0 mg/ml) >240
Carboplatin (10.0 mg/ml) >240
Carmustine (3.3 mg/ml) 23.6
Cisplatin (1.0 mg/ml) >240
Cyclophosphamide (20.0 mg/ml) >240
Cytarabine (100.0 mg/ml) >240
Dacarbazine (10 mg/ml) >240
Daunorubicin (5.0 mg/ml) >240
Docetaxel (10.0 mg/ml) >240
Doxorubicin Hydrochloride (2.0 mg/ml) >240
Epirubicin (2.0 mg/ml) >240
Etoposide (20.0 mg/ml) >240
Fludarabine (25.0 mg/ml) >240
Fluorouracil(50.0 mg/ml) >240
Gemcitabine (Gemzar) (38.0 mg/ml) >240
Idarubicin (1.0 mg/ml) >240
Ifosfamide (50.0 mg/ml) >240
Irinotecan (20.0 mg/ml) >240
Mechlorethamine HCl(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 (Taxol) (6.0 mg/ml) >240
Rituximab (10.0 mg/ml) >240
ThioTEPA (10.0 mg/ml) 36.1
Vincrinstine Sulfate(1.0 mg/ml) >240
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182948 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182948: Gammex PI Hybrid 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 5, 2026. https://510kreport.com/device/K182948
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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