510(k) · Cleared

Recalled · 2009

Esteem Blue Polyisoprene Surgical Gloves with Coating (Containing Chitosan, Provitamin B, Gluconolactone and Glycerol)

K042574510(k) TraditionalCleared Dec 8, 200477-day reviewClass I21 CFR 878.4460Recalls 8

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

Cleared on Dec 8, 2004 as substantially equivalent to K011721 (Allegiance Healthcare Corp., 2001) after a 77-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it. It has been recalled 8 times.

Decided: Dec 8, 2004
Review: 77 days
Class: Class I
Product code: KGO
Recalls: 8
Predicates: 1

Its longest line of descent runs back 1 generation to K011721 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011721 Esteem Sterile Polyisoprene Surgical GlovesAllegiance Healthcare Corp. · 2001
This deviceK042574 Esteem Blue Polyisoprene Surgical Gloves with Coating (Containing…Cardinalhealth · 2004
Descendant · cites it directly · 0 of its ownK111868 Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera…Cardinal Health-Medical Products and Services · 2011

Most influential descendants

Showing 1 of 1 · See all

K111868Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Emollient CoatingCardinal Health-Medical Products and Services · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011721	Esteem Sterile Polyisoprene Surgical Gloves	Allegiance Healthcare Corp.	2001	—
0 (this device)	K042574	Esteem Blue Polyisoprene Surgical Gloves with Coating (Containing Chitosan…	Cardinalhealth	2004	—
+1	K111868	Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Emollient…	Cardinal Health-Medical Products and Services	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K042574, 2001–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K011721	Esteem Sterile Polyisoprene Surgical Gloves	Allegiance Healthcare Corp.	2001	—

Also cleared against K011721: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111868	Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Emollient Coating	Cardinal Health-Medical Products and Services	2011	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 24, 2009	Not classified	Z-1450-2009	Device Design	Increase in the number of customer complaints due to cuff tears.
Apr 24, 2009	Not classified	Z-1451-2009	Device Design	Increase in the number of customer complaints due to cuff tears.
Apr 24, 2009	Not classified	Z-1449-2009	Device Design	Increase in the number of customer complaints due to cuff tears.
Apr 24, 2009	Not classified	Z-1452-2009	Device Design	Increase in the number of customer complaints due to cuff tears.
Apr 24, 2009	Not classified	Z-1448-2009	Device Design	Increase in the number of customer complaints due to cuff tears.
Apr 24, 2009	Not classified	Z-1447-2009	Device Design	Increase in the number of customer complaints due to cuff tears.
Apr 24, 2009	Not classified	Z-1445-2009	Device Design	Increase in the number of customer complaints due to cuff tears.
Apr 24, 2009	Not classified	Z-1446-2009	Device Design	Increase in the number of customer complaints due to cuff tears.

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?

Its one ancestor has no recall.
Of its descendants, K111868 (Cardinal Health-Medical Products and Services, 2011) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K011721.

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	—

What is it indicated for?

These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. These gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042574 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042574: Esteem Blue Polyisoprene Surgical Gloves with Coating (Containing Chitosan, Provitamin B, Gluconolactone and Glycerol).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042574

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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