510(k) · Cleared
ClearedCoated Sterile Latex Powder-Free Surgical Gloves with Protein Content Labeling Claim (50 Micrograms or Less)
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 Sep 14, 1999 after a 78-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Sep 14, 1999
- Review
- 78 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK992171 Coated Sterile Latex Powder-Free Surgical Gloves with Protein…Allegiance Healthcare Corp. · 1999
- Descendant · cites it directly · 3 of its ownK101811 Protegrity SMT Latex SurgicalglovesCardinal Health, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK111015 Sterile Latex Powder Free Surgical Gloves with Hydrogel CoatingCardinal Health, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK151778 Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical…Cardinal Health 200, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK160875 Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical…Cardinal Health, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK070647 Triflex SelectCardinal Health, Inc. · 2007
Most influential descendants
Showing 5 of 5 · See all- K101811Protegrity SMT Latex SurgicalglovesCardinal Health, Inc. · 2010 · cites it directly3descendants
- K111015Sterile Latex Powder Free Surgical Gloves with Hydrogel CoatingCardinal Health, Inc. · 2011 · 2 generations on2descendants
- K151778Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel…Cardinal Health 200, Inc. · 2016 · 3 generations on1descendant
- K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with…Cardinal Health, Inc. · 2016 · 4 generations on0descendants
- K070647Triflex SelectCardinal Health, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992171 | Coated Sterile Latex Powder-Free Surgical Gloves with Protein Content Labeling… | Allegiance Healthcare Corp. | 1999 | — |
| +1 | K101811 | Protegrity SMT Latex Surgicalgloves | Cardinal Health, Inc. | 2010 | — |
| +2 | K111015 | Sterile Latex Powder Free Surgical Gloves with Hydrogel Coating | Cardinal Health, Inc. | 2011 | — |
| +3 | K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with… | Cardinal Health 200, Inc. | 2016 | — |
| +4 | K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves… | Cardinal Health, Inc. | 2016 | — |
| +1 | K070647 | Triflex Select | Cardinal Health, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 2 | 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 |
|---|---|---|---|
| * | — | Ultrafree Sterile Latex Powder-Free Surgical Gloves Named without a submission number |
What descends from it? (5)
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?
- Of its descendants, K101811 (Cardinal Health, Inc., 2010) has gone furthest, with 3 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?
These gloves are intended for use in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.
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/K992171 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992171: Coated Sterile Latex Powder-Free Surgical Gloves with Protein Content Labeling Claim (50 Micrograms or Less).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992171
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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