510(k) · Cleared

Cleared

Barrierplus Synthetic Powder-Free Surgical Gloves

K990710510(k) TraditionalCleared May 20, 199977-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

Barriermed Glove Co. · KGO Surgeon'S Gloves

Cleared on May 20, 1999 after a 77-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: May 20, 1999
Review: 77 days
Class: Class I
Product code: KGO
Recalls: None
Predicates: 0

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

This deviceK990710 Barrierplus Synthetic Powder-Free Surgical GlovesBarriermed Glove Co. · 1999
Descendant · cites it directly · 0 of its ownK050181 Medigloves Sterile Powder-Free Synthetic Polyisoprene Surgical GlovesMedigloves, Ltd. · 2005
Descendant · cites it directly · 0 of its ownK022873 Powder-Free Radiation Attenuating Neoprene Surgical Glove (Black)International Biomedical, Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all

K050181Medigloves Sterile Powder-Free Synthetic Polyisoprene Surgical GlovesMedigloves, Ltd. · 2005 · cites it directly0descendants
K022873Powder-Free Radiation Attenuating Neoprene Surgical Glove (Black)International Biomedical, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K990710	Barrierplus Synthetic Powder-Free Surgical Gloves	Barriermed Glove Co.	1999	—
+1	K050181	Medigloves Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves	Medigloves, Ltd.	2005	—
+1	K022873	Powder-Free Radiation Attenuating Neoprene Surgical Glove (Black)	International Biomedical, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0

FIG. 1 — Lineage of K990710, 1999–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K050181	Medigloves Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves	Medigloves, Ltd.	2005	0
K022873	Powder-Free Radiation Attenuating Neoprene Surgical Glove (Black)	International Biomedical, Inc.	2003	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?

Of its descendants, K050181 (Medigloves, Ltd., 2005) has gone furthest, with 0 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 sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as non-invasive activities requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination and to protect the user from blood-borne pathogens.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K990710 · printed Nov 5, 2026

Cite this page

510(k) Report. “K990710: Barrierplus Synthetic Powder-Free Surgical Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990710

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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