510(k) · Cleared

Cleared

Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with Chemotherapy Drugs Labeling Claim

K013302510(k) TraditionalCleared Dec 17, 200175-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 Dec 17, 2001 after a 75-day review. The FDA summary names its predicate without a number. 22 later devices descend from it.

Decided: Dec 17, 2001
Review: 75 days
Class: Class I
Product code: KGO
Recalls: None
Predicates: 0

22 later devices descend from it, 6 citing it directly.

This deviceK013302 Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested…Allegiance Healthcare Corp. · 2001
Descendant · cites it directly · 7 of its ownK102500 Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health, Inc. · 2010
Descendant · cites it directly · 6 of its ownK110272 Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with…Cardinal Health, Inc. · 2011 · Recalled
Descendant · cites it directly · 5 of its ownK111139 Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical…Ansell Healthcare Products, Inc. · 2011 · Recalled
Descendant · 2 generations on · 3 of its ownK190018 Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for…Ansell Healthcare Products, LLC · 2019
Descendant · 2 generations on · 3 of its ownK122557 Motex Powder-Free Nitrile Surgical GlovesShanghai Motex Healthcare Co., Ltd. · 2013

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2010high 4 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 22 · See all

K102500Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health, Inc. · 2010 · cites it directly7descendants
K110272Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy DrugCardinal Health, Inc. · 2011 · cites it directly6descendants
K111139Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for UAnsell Healthcare Products, Inc. · 2011 · cites it directly5descendants
K190018Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy…Ansell Healthcare Products, LLC · 2019 · 2 generations on3descendants
K122557Motex Powder-Free Nitrile Surgical GlovesShanghai Motex Healthcare Co., Ltd. · 2013 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K013302	Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use…	Allegiance Healthcare Corp.	2001	—
+1	K102500	Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating	Cardinal Health, Inc.	2010	—
+1	K110272	Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with…	Cardinal Health, Inc.	2011	1
+1	K111139	Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves…	Ansell Healthcare Products, Inc.	2011	3
+2	K190018	Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with…	Ansell Healthcare Products, LLC	2019	—
+2	K122557	Motex Powder-Free Nitrile Surgical Gloves	Shanghai Motex Healthcare Co., Ltd.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	3	0
2012	1	0
2013	1	0
2014	1	0
2015	2	0
2016	2	0
2017	4	0
2019	1	0
2020	1	0
2021	1	0
2022	1	0
2023	3	0

FIG. 1 — Lineage of K013302, 2001–2023Source: 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

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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
*	—	Duraprene Sterile Powder-Free Surgical Gloves Named without a submission number			—

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K102500	Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating	Cardinal Health, Inc.	2010	7
K110272	Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drug	Cardinal Health, Inc.	2011	6
K111139	Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for U	Ansell Healthcare Products, Inc.	2011	5
K113707	Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating	Cardinal Health-Medical Products and Services	2012	2
K140477	Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove Series	Molnlycke Health Care Us, LLC	2015	1
K103714	Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemothera	Ansell Healthcare Products, LLC	2011	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, K102500 (Cardinal Health, Inc., 2010) has gone furthest, with 7 descendants 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	—

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/K013302 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013302: Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with Chemotherapy Drugs Labeling Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013302

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026