510(k) · Cleared
ClearedThe Double Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biobarrier, Inc. · KGO Surgeon'S Gloves
Cleared on Jun 27, 2006 as substantially equivalent to K033564 (Kanam Latex Industries Pvt., Ltd., 2004) after a 174-day review. Its family tree reaches back 1 generation to 2004. 4 later devices descend from it.
- Decided
- Jun 27, 2006
- Review
- 174 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033564 (2004). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK033564 Powder Free Latex Surgeons Gloves Polymer Coated Sterile with…Kanam Latex Industries Pvt., Ltd. · 2004
- This deviceK060030 The Double GloveBiobarrier, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK071465 Biogel Orthopaedic Surgical Glove with Non-Pryogenic StatementMolnlycke Health Care Us, LLC · 2007
- Descendant · cites it directly · 1 of its ownK071565 Biogel Indicator Underglove with Non-Pyrogenic StatementMolnlycke Health Care Us, LLC · 2007
- Descendant · 2 generations on · 0 of its ownK112089 Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC · 2011
- Descendant · 2 generations on · 0 of its ownK101163 Biogel Orthopro Indicator UndergloveMolnlycke Health Care USA · 2010
Most influential descendants
Showing 4 of 4 · See all- K071465Biogel Orthopaedic Surgical Glove with Non-Pryogenic StatementMolnlycke Health Care Us, LLC · 2007 · cites it directly2descendants
- K071565Biogel Indicator Underglove with Non-Pyrogenic StatementMolnlycke Health Care Us, LLC · 2007 · cites it directly1descendant
- K112089Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC · 2011 · 2 generations on0descendants
- K101163Biogel Orthopro Indicator UndergloveMolnlycke Health Care USA · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033564 | Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional… | Kanam Latex Industries Pvt., Ltd. | 2004 | — |
| 0 (this device) | K060030 | The Double Glove | Biobarrier, Inc. | 2006 | — |
| +1 | K071465 | Biogel Orthopaedic Surgical Glove with Non-Pryogenic Statement | Molnlycke Health Care Us, LLC | 2007 | — |
| +1 | K071565 | Biogel Indicator Underglove with Non-Pyrogenic Statement | Molnlycke Health Care Us, LLC | 2007 | — |
| +2 | K112089 | Biogel Orthopor Brown Surgical Glove | Molnlycke Health Care Us, LLC | 2011 | — |
| +2 | K101163 | Biogel Orthopro Indicator Underglove | Molnlycke Health Care USA | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K033564 | Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional Labeling Claim of…Summary page 1…ce: -Class I Surgeon's Gloves, Powder-free -Meets all ASTM D 3577 requirements -Predicate: K033564, Kanam Latex Industries Powder-free Latex Surgeon's Gloves Polymer Coated Sterile Contains 50… | 2004 |
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, K071465 (Molnlycke Health Care Us, LLC, 2007) 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.
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 'powder-free, polymer coated, sterile surgeon's glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060030: The Double Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060030
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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