510(k) · Cleared
ClearedBiogel Orthopaedic Surgical Glove with Non-Pryogenic Statement
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 Sep 11, 2007 as substantially equivalent to K980516 (London International Group, Inc., 1998) and 1 other predicate after a 105-day review. Its family tree reaches back 2 generations to 2004. 2 later devices descend from it.
- Decided
- Sep 11, 2007
- Review
- 105 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K033564 (2004). 3 ancestors in all, the oldest K980516 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK033564 Powder Free Latex Surgeons Gloves Polymer Coated Sterile with…Kanam Latex Industries Pvt., Ltd. · 2004
- 1 generation backK060030 The Double GloveBiobarrier, Inc. · 2006
- This deviceK071465 Biogel Orthopaedic Surgical Glove with Non-Pryogenic StatementMolnlycke Health Care Us, LLC · 2007
- Descendant · cites it directly · 0 of its ownK112089 Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC · 2011
- Descendant · cites it directly · 0 of its ownK101163 Biogel Orthopro Indicator UndergloveMolnlycke Health Care USA · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033564 | Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional… | Kanam Latex Industries Pvt., Ltd. | 2004 | — |
| −1 | K060030 | The Double Glove | Biobarrier, Inc. | 2006 | — |
| 0 (this device) | K071465 | Biogel Orthopaedic Surgical Glove with Non-Pryogenic Statement | Molnlycke Health Care Us, LLC | 2007 | — |
| +1 | K112089 | Biogel Orthopor Brown Surgical Glove | Molnlycke Health Care Us, LLC | 2011 | — |
| +1 | K101163 | Biogel Orthopro Indicator Underglove | Molnlycke Health Care USA | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K980516 | Regent Biogel Orthopedic Surgical GloveSummary page 1…Name: Classification: Surgical Glove (CFR 878.4461) Class I 4. Predicate Device: K980516 - Biogel Orthodaepic Surgical Glove K060030 - Eclipse, Non-pyrogenic, Latex, Powder-fr… | 1998 |
| * | K060030 | The Double GloveSummary page 1…Class I 4. Predicate Device: K980516 - Biogel Orthodaepic Surgical Glove K060030 - Eclipse, Non-pyrogenic, Latex, Powder-free, Glove 5. Device Description: The Biogel Orthodepic Surgical Gl… | 2006 |
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 3 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K112089 (Molnlycke Health Care Us, LLC, 2011) has gone furthest, with 0 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. 2007, 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 Orthopedic Surgeon's Glove is a disposable device made of 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/K071465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071465: Biogel Orthopaedic Surgical Glove with Non-Pryogenic Statement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071465
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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