510(k) · Cleared

Cleared

Ultrafree Max Sterile Latex Poweder-Free Surgical Gloves with Protein Labeling Claim, 50 Per Gram or Less of Total Water

K010862510(k) TraditionalCleared Jun 7, 200177-day reviewClass I21 CFR 878.4460

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Allegiance Healthcare Corp. · KGO Surgeon'S Gloves

Cleared on Jun 7, 2001 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Jun 7, 2001
Review: 77 days
Class: Class I
Product code: KGO
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK010862 Ultrafree Max Sterile Latex Poweder-Free Surgical Gloves with…Allegiance Healthcare Corp. · 2001
Descendant · cites it directly · 1 of its ownK092304 Esteem Ortho Polyisoprene Powder-Free Surgical GlovesCardinal Health, Inc. · 2009
Descendant · 2 generations on · 0 of its ownK160875 Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical…Cardinal Health, Inc. · 2016

Most influential descendants

Showing 2 of 2 · See all

K092304Esteem Ortho Polyisoprene Powder-Free Surgical GlovesCardinal Health, Inc. · 2009 · cites it directly1descendant
K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with…Cardinal Health, Inc. · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010862	Ultrafree Max Sterile Latex Poweder-Free Surgical Gloves with Protein Labeling…	Allegiance Healthcare Corp.	2001	—
+1	K092304	Esteem Ortho Polyisoprene Powder-Free Surgical Gloves	Cardinal Health, Inc.	2009	—
+2	K160875	Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves…	Cardinal Health, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2016	1	0

FIG. 1 — Lineage of K010862, 2001–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Descendants
K092304	Esteem Ortho Polyisoprene Powder-Free Surgical Gloves	Cardinal Health, Inc.	2009	1

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, K092304 (Cardinal Health, Inc., 2009) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KGO devices

KGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGO

1in 2025

2007high 15 (2020) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGO

185in 2023

2007high 257 (2014) · low 48 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KGO

2in 2023

2007high 15 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KGO

21in 2025

2007high 51 (2019) · low 8 (2008)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/K010862 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010862: Ultrafree Max Sterile Latex Poweder-Free Surgical Gloves with Protein Labeling Claim, 50 Per Gram or Less of Total Water.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010862

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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