510(k) · Cleared

Cleared

Biogel Sensor Surgeon's Glove with Non-Pyrogenic Statement

K071700510(k) TraditionalCleared Sep 11, 200782-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

Molnlycke Health Care Us, LLC · KGO Surgeon'S Gloves

Cleared on Sep 11, 2007 as substantially equivalent to K053443 (Regent Medical Americas, LLC, 2006) after an 82-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.

Decided: Sep 11, 2007
Review: 82 days
Class: Class I
Product code: KGO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K053443 (2006). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK053443 Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's GloveRegent Medical Americas, LLC · 2006
This deviceK071700 Biogel Sensor Surgeon's Glove with Non-Pyrogenic StatementMolnlycke Health Care Us, LLC · 2007
Descendant · cites it directly · 0 of its ownK112089 Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC · 2011

Most influential descendants

Showing 1 of 1 · See all

K112089Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K053443	Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's Glove	Regent Medical Americas, LLC	2006	—
0 (this device)	K071700	Biogel Sensor Surgeon's Glove with Non-Pyrogenic Statement	Molnlycke Health Care Us, LLC	2007	—
+1	K112089	Biogel Orthopor Brown Surgical Glove	Molnlycke Health Care Us, LLC	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K071700, 2006–2011Source: 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
*	K053443	Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's Glove Summary page 1 …ment Common Name: Surgical Glove (CER 878.4464) Classification: Class I 4. Predicate Device: K053443 - Eclipse, Non-pyrogenic, Latex, Powder-free, Glove 5. Device Description: The Biogel® SensorTM Surgeon's Gl…	Regent Medical Americas, LLC	2006	—

Also cleared against K053443: 1 other device →

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
K112089	Biogel Orthopor Brown Surgical Glove	Molnlycke Health Care Us, LLC	2011	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, K112089 (Molnlycke Health Care Us, LLC, 2011) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K053443.

How does its category compare?

All KGO devices

KGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

The Biogel® SensorTM Surgeon's Glove is a sterile disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071700 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071700: Biogel Sensor Surgeon's Glove with Non-Pyrogenic Statement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071700

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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