510(k) · Cleared

Cleared

Gammex PI Breach Detect Powder Free Surgical Glove

K171375510(k) TraditionalCleared Feb 6, 2018272-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

Ansell Healthcare Products, LLC · KGO Surgeon'S Gloves

Cleared on Feb 6, 2018 as substantially equivalent to K071746 (Ansell Healthcare Products, LLC, 2007) after a 272-day review. Its family tree reaches back 1 generation to 2007.

Decided: Feb 6, 2018
Review: 272 days
Class: Class I
Product code: KGO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K071746 (2007). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK071746 Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic…Ansell Healthcare Products, LLC · 2007
This deviceK171375 Gammex PI Breach Detect Powder Free Surgical GloveAnsell Healthcare Products, LLC · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K071746	Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene…	Ansell Healthcare Products, LLC	2007	—
0 (this device)	K171375	Gammex PI Breach Detect Powder Free Surgical Glove	Ansell Healthcare Products, LLC	2018	—

FIG. 1 — Lineage of K171375, 2007–2018Source: 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
*	K071746	Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene Surgical… Summary page 4 …21 CFR 878.4460 Device Class: I Product Code: KGO Classification Panel: General and Plastic Surgery Legally Marketed Predicate Device K071746 – DermaPrene® PI or IsoTouch Green Sterile Powder-Free Polyisoprene Surgical Gloves Common Name: Surgeon’s Gloves C…	Ansell Healthcare Products, LLC	2007	—

Also cleared against K071746: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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.
1 other device also cites its predicate K071746.

How does its category compare?

All KGO devices

KGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?

Gammex PI Breach Detect Powder Free Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K171375 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171375: Gammex PI Breach Detect Powder Free Surgical Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171375

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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