510(k) · Cleared
ClearedGammex PI Hybrid Surgical Gloves
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 9, 2016 as substantially equivalent to K071746 (Ansell Healthcare Products, LLC, 2007) after a 260-day review. Its family tree reaches back 1 generation to 2007. 5 later devices descend from it.
- Decided
- Mar 9, 2016
- Review
- 260 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071746 (2007). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK071746 Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic…Ansell Healthcare Products, LLC · 2007
- This deviceK151694 Gammex PI Hybrid Surgical GlovesAnsell Healthcare Products, LLC · 2016
- Descendant · cites it directly · 2 of its ownK171047 Sterile Polyisoprene Powder Free Surgical GlovesBetter Care Plastic Technology Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK182948 Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy…Ansell Healthcare Products, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK231902 GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro…Ansell Healthcare · 2023
- Descendant · 2 generations on · 0 of its ownK230304 Polyisoprene Surgical GlovesPuyang Linshi Medical Supplies Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK203483 Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical GlovesGuilin Hbm Health Protections, Inc. · 2021
Most influential descendants
Showing 5 of 5 · See all- K171047Sterile Polyisoprene Powder Free Surgical GlovesBetter Care Plastic Technology Co., Ltd. · 2017 · cites it directly2descendants
- K182948Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy DrugsAnsell Healthcare Products, LLC · 2019 · cites it directly1descendant
- K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid…Ansell Healthcare · 2023 · 2 generations on0descendants
- K230304Polyisoprene Surgical GlovesPuyang Linshi Medical Supplies Co., Ltd. · 2023 · 2 generations on0descendants
- K203483Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical GlovesGuilin Hbm Health Protections, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071746 | Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene… | Ansell Healthcare Products, LLC | 2007 | — |
| 0 (this device) | K151694 | Gammex PI Hybrid Surgical Gloves | Ansell Healthcare Products, LLC | 2016 | — |
| +1 | K171047 | Sterile Polyisoprene Powder Free Surgical Gloves | Better Care Plastic Technology Co., Ltd. | 2017 | — |
| +1 | K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | 2019 | — |
| +2 | K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX… | Ansell Healthcare | 2023 | — |
| +2 | K230304 | Polyisoprene Surgical Gloves | Puyang Linshi Medical Supplies Co., Ltd. | 2023 | — |
| +2 | K203483 | Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves | Guilin Hbm Health Protections, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K071746 | Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene Surgical…Summary page 4…78.4460 Device Class: I Product Code: KGO Classification Panel: General and Plastic Surgery Legally Marketed Predicate Device K071746 – Derma Prene PI or Isotouch Green sterile Powder-Free Synthetic Polyisoprene Surgical Gloves Device Description The subject dev… | 2007 |
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)
No FDA recall names this device.
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. 2016, 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 Glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151694: Gammex PI Hybrid Surgical Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151694
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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