510(k) · Cleared
ClearedBiogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator 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 May 24, 2019 as substantially equivalent to K050184 (Regent Medical Americas, LLC, 2005) and 1 other predicate after a 128-day review. Its family tree reaches back 2 generations to 2008. 2 later devices descend from it.
- Decided
- May 24, 2019
- Review
- 128 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K081180 (2008). 3 ancestors in all, the oldest K050184 (2005). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK081180 Skinsense Polyisoprene UndergloveMolnlycke Health Care Us, LLC · 2008
- 1 generation backK111413 Biogel (R) Indicator (R) UndergloveMolnlycke Health Care Us, LLC · 2012
- This deviceK190077 Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S…Molnlycke Health Care Us, LLC · 2019
- Descendant · cites it directly · 0 of its ownK213289 Gammex® PI Plus Glove-in-Glove™ System Tested For Use with…Ansell Healthcare Products, LLC · 2023
- Descendant · cites it directly · 0 of its ownK191869 Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis…Molnlycke Health Care Us, LLC · 2020
Most influential descendants
Showing 2 of 2 · See all- K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsAnsell Healthcare Products, LLC · 2023 · cites it directly0descendants
- K191869Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel…Molnlycke Health Care Us, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K081180 | Skinsense Polyisoprene Underglove | Molnlycke Health Care Us, LLC | 2008 | — |
| −1 | K111413 | Biogel (R) Indicator (R) Underglove | Molnlycke Health Care Us, LLC | 2012 | — |
| 0 (this device) | K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator… | Molnlycke Health Care Us, LLC | 2019 | — |
| +1 | K213289 | Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | 2023 | — |
| +1 | K191869 | Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential… | Molnlycke Health Care Us, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K050184 | Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex GloveSummary page 4…cate Device Name(s): Biogel® PI UltraTouch Surgical Glove (SKINSENSE® POLY- ISOPRENE POWDER-FREE NON-LATEX GLOVE, K050184), Biogel® Indicator Underglove (BIOGEL® INDICATOR ®… | 2005 |
| * | K111413 | Biogel (R) Indicator (R) UndergloveSummary page 4…ON-LATEX GLOVE, K050184), Biogel® Indicator Underglove (BIOGEL® INDICATOR ® UNDERGLOVE, K111413) Description of Device: Subject of this submission are two surgical gloves: a single-use, sterile, straw-colored overglove whic… | 2012 |
What descends from it? (2)
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?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 7.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K213289 (Ansell Healthcare Products, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K050184.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 UltraTouch S Surgical Glove is a disposable device made of polyisoprene, 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.
The Biogel® PI UltraTouch S Indicator Underglove is a disposable device made of polyisoprene, blue in color, 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/K190077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190077: Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190077
Report an extraction error
Are you the manufacturer?
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