510(k) · Cleared
ClearedBiogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Regent Medical Americas, LLC · KGO Surgeon'S Gloves
Cleared on Feb 1, 2006 after a 54-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Feb 1, 2006
- Review
- 54 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK053443 Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's GloveRegent Medical Americas, LLC · 2006
- Descendant · cites it directly · 1 of its ownK071700 Biogel Sensor Surgeon's Glove with Non-Pyrogenic StatementMolnlycke Health Care Us, LLC · 2007
- Descendant · cites it directly · 1 of its ownK062847 Biogel Eclipse Indicator UndergloveMolnlycke Health Care Us, LLC · 2006
- Descendant · 2 generations on · 0 of its ownK112089 Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC · 2011
- Descendant · 2 generations on · 0 of its ownK071414 Biogel Eclipse, Latex, Powder Free, Indicator Underglove with…Molnlycke Health Care Us, LLC · 2007
Most influential descendants
Showing 4 of 4 · See all- K071700Biogel Sensor Surgeon's Glove with Non-Pyrogenic StatementMolnlycke Health Care Us, LLC · 2007 · cites it directly1descendant
- K062847Biogel Eclipse Indicator UndergloveMolnlycke Health Care Us, LLC · 2006 · cites it directly1descendant
- K112089Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC · 2011 · 2 generations on0descendants
- K071414Biogel Eclipse, Latex, Powder Free, Indicator Underglove with Protein Content Labeling…Molnlycke Health Care Us, LLC · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053443 | Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's Glove | Regent Medical Americas, LLC | 2006 | — |
| +1 | K071700 | Biogel Sensor Surgeon's Glove with Non-Pyrogenic Statement | Molnlycke Health Care Us, LLC | 2007 | — |
| +1 | K062847 | Biogel Eclipse Indicator Underglove | Molnlycke Health Care Us, LLC | 2006 | — |
| +2 | K112089 | Biogel Orthopor Brown Surgical Glove | Molnlycke Health Care Us, LLC | 2011 | — |
| +2 | K071414 | Biogel Eclipse, Latex, Powder Free, Indicator Underglove with Protein Content… | Molnlycke Health Care Us, LLC | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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?
- Of its descendants, K071700 (Molnlycke Health Care Us, LLC, 2007) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 sterile surgeon's glove is a disposable device made of de-prolenised latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K053443 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053443: Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053443
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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