510(k) · Cleared
ClearedGAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ansell Healthcare · KGO Surgeon'S Gloves
Cleared on Oct 20, 2023 as substantially equivalent to K182948 (Ansell Healthcare Products, LLC, 2019) after a 114-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Oct 20, 2023
- Review
- 114 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K071746 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backK071746 Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic…Ansell Healthcare Products, LLC · 2007
- 2 generations backK151694 Gammex PI Hybrid Surgical GlovesAnsell Healthcare Products, LLC · 2016
- 1 generation backK182948 Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy…Ansell Healthcare Products, LLC · 2019
- This deviceK231902 GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro…Ansell Healthcare · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K071746 | Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene… | Ansell Healthcare Products, LLC | 2007 | — |
| −2 | K151694 | Gammex PI Hybrid Surgical Gloves | Ansell Healthcare Products, LLC | 2016 | — |
| −1 | K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | 2019 | — |
| 0 (this device) | K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX… | Ansell Healthcare | 2023 | — |
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 |
|---|---|---|---|
| * | K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy DrugsSummary page 6…Product Code: KGO, OPJ Classification Panel: General and Plastic Surgery Legally Marketed Predicate Device K182948 Trade Name: Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs Common N… | 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 16 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
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?
Gammex PI Hybrid Micro Surgical Gloves are sterile, non-pyrogenic, are intended to be worn by operating room personnel to protect a surgical wound from contamination and have a shelf life of 3 years. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Test chemotherapy drug and concentration — Minimum…
Read the full statement (233 words)
Gammex PI Hybrid Micro Surgical Gloves are sterile, non-pyrogenic, are intended to be worn by operating room personnel to protect a surgical wound from contamination and have a shelf life of 3 years. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
Test chemotherapy drug and concentration — Minimum breakthrough detection time in minutes
Bleomycin (15.0 mg/ml) — >240
Busulfan (6.0 mg/ml) — >240
Carboplatin (10.0 mg/ml) — >240
Carmustine (3.3 mg/ml) — 24.1
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 HCl (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 (25.0 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 (5.0mg/ml) — >240
Methotrexate (25.0 mg/ml) — >240
Mitomycin C (0.5 mg/ml) — >240
Mitoxantrone (2.0mg/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) — 26.0
Vincristine Sulfate (1.0 mg/ml) — >240
Warning: Do not use with Carmustine or ThioTEPA
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K231902: GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K231902
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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