510(k) · Cleared
ClearedBiogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove Series
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 Mar 23, 2015 as substantially equivalent to K050184 (Regent Medical Americas, LLC, 2005) and 3 other predicates after a 390-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Mar 23, 2015
- Review
- 390 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K011721 (2001). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK011721 Esteem Sterile Polyisoprene Surgical GlovesAllegiance Healthcare Corp. · 2001
- 2 generations backK093300 Esteem SMT Polyisoprene Powder-Free Surgical Sterile GlovesCardinal Health, Inc. · 2009
- 1 generation backK110272 Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with…Cardinal Health, Inc. · 2011 · Recalled
- This deviceK140477 Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove…Molnlycke Health Care Us, LLC · 2015
- Descendant · cites it directly · 0 of its ownK193573 Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel…Molnlycke Health Care Us, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator…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 |
|---|---|---|---|---|---|
| −3 | K011721 | Esteem Sterile Polyisoprene Surgical Gloves | Allegiance Healthcare Corp. | 2001 | — |
| −2 | K093300 | Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves | Cardinal Health, Inc. | 2009 | — |
| −1 | K110272 | Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with… | Cardinal Health, Inc. | 2011 | 1 |
| 0 (this device) | K140477 | Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove Series | Molnlycke Health Care Us, LLC | 2015 | — |
| +1 | K193573 | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI… | Molnlycke Health Care Us, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (4)
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 7…KGO [primary] LZC Predicate Device Name(s): Biogel® PI (polyisoprene) Surgical Gloves (K050184) Biogel ® Skinsense® (polychloroprene) Surgical Glove… | 2005 |
| * | K053102 | Biogel Skinsense Powder-Free Non-Latex Surgeon's GloveSummary page 7…es (K050184) Biogel ® Skinsense® (polychloroprene) Surgical Glove (K053102) Cardinal Health Esteem Polyisoprene Powder Free… | 2006 |
| * | K110272 | Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy DrugSummary page 7…2) Cardinal Health Esteem Polyisoprene Powder Free Surgical Glove (K110272) Cardinal Health (Allegance) Dermaprene… | 2011 |
| * | K013302 | Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with…Summary page 7…e (K110272) Cardinal Health (Allegance) Dermaprene Surgical Glove (K013302) Description of Device: The subject devices are disposable powder-free surgical gloves that are supplied st… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193573 | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator… | 2020 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K193573 (Molnlycke Health Care Us, LLC, 2020) 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. 2015, 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?
Biogel® Skinsense® Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material, and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Biogel® PI UltraTouch™ G Surgical Gloves are intended to be worn on the hands…
Read the full statement (110 words)
Biogel® Skinsense® Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material, and other contaminants.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Biogel® PI UltraTouch™ G Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material, and other contaminants.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140477: Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140477
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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