510(k) · Cleared
ClearedSkinsense Polyisoprene Underglove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Molnlycke Health Care Us, LLC · KGO Surgeon'S Gloves
Cleared on Aug 26, 2008 after a 123-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Aug 26, 2008
- Review
- 123 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK081180 Skinsense Polyisoprene UndergloveMolnlycke Health Care Us, LLC · 2008
- Descendant · cites it directly · 4 of its ownK111413 Biogel (R) Indicator (R) UndergloveMolnlycke Health Care Us, LLC · 2012
- Descendant · 2 generations on · 2 of its ownK190077 Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S…Molnlycke Health Care Us, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK213289 Gammex® PI Plus Glove-in-Glove™ System Tested For Use with…Ansell Healthcare Products, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK191869 Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis…Molnlycke Health Care Us, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK150146 Biogel PI Micro Indicator UndergloveMolnlycke Health Care Us, LLC · 2015
Most influential descendants
Showing 5 of 5 · See all- K111413Biogel (R) Indicator (R) UndergloveMolnlycke Health Care Us, LLC · 2012 · cites it directly4descendants
- K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveMolnlycke Health Care Us, LLC · 2019 · 2 generations on2descendants
- K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsAnsell Healthcare Products, LLC · 2023 · 3 generations on0descendants
- K191869Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel…Molnlycke Health Care Us, LLC · 2020 · 3 generations on0descendants
- K150146Biogel PI Micro Indicator UndergloveMolnlycke Health Care Us, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081180 | Skinsense Polyisoprene Underglove | Molnlycke Health Care Us, LLC | 2008 | — |
| +1 | K111413 | Biogel (R) Indicator (R) Underglove | Molnlycke Health Care Us, LLC | 2012 | — |
| +2 | K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator… | Molnlycke Health Care Us, LLC | 2019 | — |
| +3 | K213289 | Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | 2023 | — |
| +3 | K191869 | Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential… | Molnlycke Health Care Us, LLC | 2020 | — |
| +2 | K150146 | Biogel PI Micro Indicator Underglove | Molnlycke Health Care Us, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111413 | Biogel (R) Indicator (R) Underglove | 2012 | 4 |
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, K111413 (Molnlycke Health Care Us, LLC, 2012) has gone furthest, with 4 descendants 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. 2008, 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?
The Skinsense Polyisoprene Underglove is a disposable device made of non-natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081180 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081180: Skinsense Polyisoprene Underglove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081180
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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