510(k) · Cleared

Cleared

Biogel PI Orthopro Brown Surgical Glove

K112257510(k) SpecialCleared Sep 20, 201146-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 20, 2011 as substantially equivalent to K050184 (Regent Medical Americas, LLC, 2005) after a 46-day review. Its family tree reaches back 1 generation to 2005.

Decided: Sep 20, 2011
Review: 46 days
Class: Class I
Product code: KGO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K050184 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK050184 Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex GloveRegent Medical Americas, LLC · 2005
This deviceK112257 Biogel PI Orthopro Brown Surgical GloveMolnlycke Health Care Us, LLC · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K050184	Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove	Regent Medical Americas, LLC	2005	—
0 (this device)	K112257	Biogel PI Orthopro Brown Surgical Glove	Molnlycke Health Care Us, LLC	2011	—

FIG. 1 — Lineage of K112257, 2005–2011Source: 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

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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
*	K050184	Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove Summary page 2 …ical Characteristics: The Biogel® PI OrthoPro® Brown Surgical Glove is substantially equivalent to the Poly- isoprene Non-Latex Sterile Powder-Free Surgeon's Glove (K050184). All of the assessed devices have similar indications for use, materials, product design, labeling claims and method of oper…	Regent Medical Americas, LLC	2005	—

Also cleared against K050184: 4 other devices →

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.
4 other devices also cite its predicate K050184.

How does its category compare?

All KGO devices

KGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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® PI OrthoPro® Brown Surgical Glove is a disposable device made of non-latex (polyisoprene) colored brown, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K112257 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112257: Biogel PI Orthopro Brown 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/K112257

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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