510(k) · Cleared
ClearedBiogel Orthopor Brown Surgical Glove
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 24, 2011 as substantially equivalent to K071700 (Molnlycke Health Care Us, LLC, 2007) and 1 other predicate after a 34-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Aug 24, 2011
- Review
- 34 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K033564 (2004). 6 ancestors in all, the oldest K980516 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK033564 Powder Free Latex Surgeons Gloves Polymer Coated Sterile with…Kanam Latex Industries Pvt., Ltd. · 2004
- 2 generations backK060030 The Double GloveBiobarrier, Inc. · 2006
- 1 generation backK071465 Biogel Orthopaedic Surgical Glove with Non-Pryogenic StatementMolnlycke Health Care Us, LLC · 2007
- This deviceK112089 Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K033564 | Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional… | Kanam Latex Industries Pvt., Ltd. | 2004 | — |
| −2 | K060030 | The Double Glove | Biobarrier, Inc. | 2006 | — |
| −1 | K071465 | Biogel Orthopaedic Surgical Glove with Non-Pryogenic Statement | Molnlycke Health Care Us, LLC | 2007 | — |
| 0 (this device) | K112089 | Biogel Orthopor Brown Surgical Glove | Molnlycke Health Care Us, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K071700 | Biogel Sensor Surgeon's Glove with Non-Pyrogenic StatementSummary page 1…Predicate Device Name(s): Biogel® Sensor Surgeons Glove (K071 700) Biogel® Orthopedic Surgical Glove… | 2007 |
| * | K071465 | Biogel Orthopaedic Surgical Glove with Non-Pryogenic StatementSummary page 1…(K071 700) Biogel® Orthopedic Surgical Glove (K07 1465) Description of Device: The proposed device, the Biogel® OrthoPro® Brown Sur… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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® OzthoPro®Brown Surgical Glove isadisposable device miadeofnatwal rubber latex that is intended to be wvornon the hands, usually in asurgical setting,to provide abarrier against potentially infectiousnmaterial and other containimints.
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/K112089 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112089: Biogel Orthopor Brown Surgical Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112089
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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