510(k) · Cleared
Recalled · Class II · 2020Coated Sterile Latex Powdeer-Free Surgical Gloves with Protein Content Labeling Claim (50 Microgram or LESS0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allegiance Healthcare Corp. · KGO Surgeon'S Gloves
Cleared on Jul 14, 2000 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 8 times.
- Decided
- Jul 14, 2000
- Review
- 21 days
- Class
- Class I
- Product code
- KGO
- Recalls
- 8
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK001924 Coated Sterile Latex Powdeer-Free Surgical Gloves with Protein…Allegiance Healthcare Corp. · 2000
- Descendant · cites it directly · 1 of its ownK053272 Cardinal Health Protegrity Blue with Neu-Thera Surgical GlovesCardinalhealth · 2006
- Descendant · 2 generations on · 0 of its ownK111878 Protexis Latex Blue with Neu-Thera Powder-Free Surgical GlovesCardinal Health, Inc. · 2011
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 |
|---|---|---|---|---|---|
| 0 (this device) | K001924 | Coated Sterile Latex Powdeer-Free Surgical Gloves with Protein Content… | Allegiance Healthcare Corp. | 2000 | — |
| +1 | K053272 | Cardinal Health Protegrity Blue with Neu-Thera Surgical Gloves | Cardinalhealth | 2006 | — |
| +2 | K111878 | Protexis Latex Blue with Neu-Thera Powder-Free Surgical Gloves | Cardinal Health, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053272 | Cardinal Health Protegrity Blue with Neu-Thera Surgical Gloves | 2006 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2020 | Class II | Z-2916-2020 | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| Jul 29, 2020 | Class II | Z-2913-2020 | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| Jul 29, 2020 | Class II | Z-2919-2020 | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| Jul 29, 2020 | Class II | Z-2917-2020 | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| Jul 29, 2020 | Class II | Z-2918-2020 | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| Jul 29, 2020 | Class II | Z-2914-2020 | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| Jul 29, 2020 | Class II | Z-2915-2020 | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| Jul 29, 2020 | Class II | Z-2912-2020 | Under Investigation by firm | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053272 (Cardinalhealth, 2006) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K001924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001924: Coated Sterile Latex Powdeer-Free Surgical Gloves with Protein Content Labeling Claim (50 Microgram or LESS0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001924
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026