510(k) · Cleared

Cleared

Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves

K093300510(k) TraditionalCleared Oct 30, 20099-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

Cardinal Health, Inc. · KGO Surgeon'S Gloves

Cleared on Oct 30, 2009 as substantially equivalent to K011721 (Allegiance Healthcare Corp., 2001) after a 9-day review. Its family tree reaches back 1 generation to 2001. 8 later devices descend from it.

Decided: Oct 30, 2009
Review: 9 days
Class: Class I
Product code: KGO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011721 (2001). 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK011721 Esteem Sterile Polyisoprene Surgical GlovesAllegiance Healthcare Corp. · 2001
This deviceK093300 Esteem SMT Polyisoprene Powder-Free Surgical Sterile GlovesCardinal Health, Inc. · 2009
Descendant · cites it directly · 6 of its ownK110272 Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with…Cardinal Health, Inc. · 2011 · Recalled
Descendant · 2 generations on · 2 of its ownK152428 SensiCare PI Surgical GlovesMedline Industries, Inc. · 2016
Descendant · 2 generations on · 1 of its ownK140477 Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove…Molnlycke Health Care Us, LLC · 2015
Descendant · 3 generations on · 0 of its ownK193573 Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel…Molnlycke Health Care Us, LLC · 2020
Descendant · 3 generations on · 0 of its ownK171898 Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use…Better Care Plastic Technology Co., Ltd. · 2017

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2011high 3 (2017) · low 0 (2012)2026

Most influential descendants

Showing 5 of 8 · See all

K110272Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy DrugCardinal Health, Inc. · 2011 · cites it directly6descendants
K152428SensiCare PI Surgical GlovesMedline Industries, Inc. · 2016 · 2 generations on2descendants
K140477Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove SeriesMolnlycke Health Care Us, LLC · 2015 · 2 generations on1descendant
K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator…Molnlycke Health Care Us, LLC · 2020 · 3 generations on0descendants
K171898Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy DrugsBetter Care Plastic Technology Co., Ltd. · 2017 · 3 generations on0descendants

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)	K093300	Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves	Cardinal Health, Inc.	2009	—
+1	K110272	Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with…	Cardinal Health, Inc.	2011	1
+2	K152428	SensiCare PI Surgical Gloves	Medline Industries, Inc.	2016	—
+2	K140477	Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove Series	Molnlycke Health Care Us, LLC	2015	—
+3	K193573	Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI…	Molnlycke Health Care Us, LLC	2020	—
+3	K171898	Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With…	Better Care Plastic Technology Co., Ltd.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2014	1	0
2015	1	0
2016	1	0
2017	3	0
2020	1	0

FIG. 1 — Lineage of K093300, 2001–2020Source: 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? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K110272	Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drug	Cardinal Health, Inc.	2011	6
K123126	Motex Polyisoprene Powder-Free Surgical Gloves Model # 6412(6432) and # 6512(6532)	Shanghai Motex Healthcare Co., Ltd.	2014	0

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, K110272 (Cardinal Health, Inc., 2011) has gone furthest, with 6 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. 2009, this device’s year, is highlighted.

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 powder-free surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093300 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093300: Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093300

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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