510(k) · Cleared
ClearedBiogel (R) Indicator (R) 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 Jan 30, 2012 as substantially equivalent to K081180 (Molnlycke Health Care Us, LLC, 2008) after a 255-day review. Its family tree reaches back 1 generation to 2008. 4 later devices descend from it.
- Decided
- Jan 30, 2012
- Review
- 255 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K081180 (2008). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK081180 Skinsense Polyisoprene UndergloveMolnlycke Health Care Us, LLC · 2008
- This deviceK111413 Biogel (R) Indicator (R) UndergloveMolnlycke Health Care Us, LLC · 2012
- Descendant · cites it directly · 2 of its ownK190077 Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S…Molnlycke Health Care Us, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK213289 Gammex® PI Plus Glove-in-Glove™ System Tested For Use with…Ansell Healthcare Products, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK191869 Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis…Molnlycke Health Care Us, LLC · 2020
- Descendant · cites it directly · 0 of its ownK150146 Biogel PI Micro Indicator UndergloveMolnlycke Health Care Us, LLC · 2015
Most influential descendants
Showing 4 of 4 · See all- K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveMolnlycke Health Care Us, LLC · 2019 · cites it directly2descendants
- K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsAnsell Healthcare Products, LLC · 2023 · 2 generations on0descendants
- K191869Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel…Molnlycke Health Care Us, LLC · 2020 · 2 generations on0descendants
- K150146Biogel PI Micro Indicator UndergloveMolnlycke Health Care Us, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K081180 | Skinsense Polyisoprene Underglove | Molnlycke Health Care Us, LLC | 2008 | — |
| 0 (this device) | K111413 | Biogel (R) Indicator (R) Underglove | Molnlycke Health Care Us, LLC | 2012 | — |
| +1 | K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator… | Molnlycke Health Care Us, LLC | 2019 | — |
| +2 | K213289 | Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | 2023 | — |
| +2 | K191869 | Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential… | Molnlycke Health Care Us, LLC | 2020 | — |
| +1 | K150146 | Biogel PI Micro Indicator Underglove | Molnlycke Health Care Us, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K081180 | Skinsense Polyisoprene UndergloveSummary page 1…Name(s): Disciiptldii of Dvice: Bigél® PITndicator® Underglove Surgeon’s Glove Surgeon’s Glove Cligs 1 B 21 CFR 878.4460 KGO Biogel® PI: lnd[cat01'9 Underglove (K081180 -~ orlg,mally clearcd under. Skinsense. Polytsopreue Undergiove) ‘-The proposcd dc\'lcc, the: B:o,gclxw Pl Indlcator Underglove… | 2008 |
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?
- Its one ancestor has no recall.
- Of its descendants, K190077 (Molnlycke Health Care Us, LLC, 2019) has gone furthest, with 2 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. 2012, 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 Biogel® PI Indicator® Underglove is a disposable device made of polyisoprene blue in color to protect against potentially infectious material and other contaminants.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111413 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111413: Biogel (R) Indicator (R) Underglove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111413
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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