510(k) Report

510(k) · Cleared

Cleared

Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove

K050184510(k) TraditionalCleared Mar 16, 200548-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

Regent Medical Americas, LLC · KGO Surgeon'S Gloves

Cleared on Mar 16, 2005 after a 48-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.

Decided
Mar 16, 2005
Review
48 days
Class
Class I
Product code
KGO
Recalls
None
Predicates
0

8 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2014: 1 descendant cleared2011: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant cleared2020: 2 descendants cleared2023: 1 descendant cleared20052010201520202025
  1. This deviceK050184 Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex GloveRegent Medical Americas, LLC · 2005
  2. Descendant · cites it directly · 2 of its ownK190077 Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S…Molnlycke Health Care Us, LLC · 2019
  3. Descendant · cites it directly · 1 of its ownK140477 Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove…Molnlycke Health Care Us, LLC · 2015
  4. Descendant · 2 generations on · 0 of its ownK213289 Gammex® PI Plus Glove-in-Glove™ System Tested For Use with…Ansell Healthcare Products, LLC · 2023
  5. Descendant · 2 generations on · 0 of its ownK193573 Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel…Molnlycke Health Care Us, LLC · 2020
  6. Descendant · 2 generations on · 0 of its ownK191869 Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis…Molnlycke Health Care Us, LLC · 2020

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2008: 12011: 12014: 12015: 12019: 12020: 22023: 1
2008high 2 (2020) · low 0 (2009)2026

Most influential descendants

Showing 5 of 8 · See all
  • K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveMolnlycke Health Care Us, LLC · 2019 · cites it directly2descendants
  • K140477Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove SeriesMolnlycke Health Care Us, LLC · 2015 · cites it directly1descendant
  • K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsAnsell Healthcare Products, LLC · 2023 · 2 generations on0descendants
  • K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator…Molnlycke Health Care Us, LLC · 2020 · 2 generations on0descendants
  • K191869Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel…Molnlycke Health Care Us, LLC · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K050184Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex GloveRegent Medical Americas, LLC2005—
+1K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator…Molnlycke Health Care Us, LLC2019—
+1K140477Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove SeriesMolnlycke Health Care Us, LLC2015—
+2K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsAnsell Healthcare Products, LLC2023—
+2K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI…Molnlycke Health Care Us, LLC2020—
+2K191869Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential…Molnlycke Health Care Us, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201410
201510
201910
202020
202310
FIG. 1 — Lineage of K050184, 2005–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192328 JR.MEDIK Latex Surgeon’s Gloves Powder Freescore 15.2 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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? (8)

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

NumberDeviceApplicantDecidedDescendants
K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveMolnlycke Health Care Us, LLC20192
K140477Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove SeriesMolnlycke Health Care Us, LLC20151
K141719Biogel PL Micro Surgical GloveMolnlycke Health Care Us, LLC20140
K112257Biogel PI Orthopro Brown Surgical GloveMolnlycke Health Care Us, LLC20110
K072169Durex Synthetic Polyisoprene Male CondomSsl Americas, Inc.20080

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, K190077 (Molnlycke Health Care Us, LLC, 2019) has gone furthest, with 2 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

2007: 102008: 22009: 32010: 62011: 112012: 72013: 62014: 72015: 122016: 92017: 122018: 72019: 112020: 152021: 142022: 62023: 142024: 22025: 12026 (partial year): 2
2007high 15 (2020) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGO

185in 2023

2007: 113 days median2009: 48 days median2010: 87 days median2011: 90 days median2012: 133 days median2013: 184 days median2014: 257 days median2015: 225 days median2016: 218 days median2017: 111 days median2018: 194 days median2019: 204 days median2020: 117 days median2021: 199 days median2022: 127 days median2023: 185 days median
2007high 257 (2014) · low 48 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KGO

2in 2023

2009: 152010: 12016: 22017: 12018: 82022: 22023: 2
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

2007: 132008: 82009: 142010: 162011: 142012: 142013: 412014: 282015: 112016: 152017: 202018: 152019: 512020: 152021: 142022: 102023: 282024: 182025: 21
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200710113013
20082—08
20093481514
2010687116
20111190014
20127133014
20136184041
20147257028
201512225011
20169218215
201712111120
20187194815
201911204051
202015117015
202114199014
20226127210
202314185228
20242—018
20251—021
20262—0—

What is it indicated for?

A powder-free sterile surgeon's glove is a disposable device made of Poly-Isop)rene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Indications for use as stated in the FDA 510(k) statement.

More from Regent Medical Americas, LLC

7 FDA decisions under this applicant name. See the company

  • K053441Biogel Latex Powder Free Sterile Surgeon's GloveRegent Medical Americas, LLC · 2006
  • K053102Biogel Skinsense Powder-Free Non-Latex Surgeon's GloveRegent Medical Americas, LLC · 2006
  • K053442Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex GloveRegent Medical Americas, LLC · 2006
  • K053443Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's GloveRegent Medical Americas, LLC · 2006
  • K050899Biogel Latex Sterile Powder-Free GloveRegent Medical Americas, LLC · 2005

Recent decisions in KGO

The KGO category page

  • K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder…Hartalega NGC Sdn. Bhd. · 2026
  • K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company Limited · 2026
  • K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs…Harps Europe Manufacturing GmbH · 2025
  • K240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd. · 2024
  • K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and…Wrp Asia Pacific Sdn. Bhd. · 2024

https://510kreport.com/device/K050184 · printed Nov 5, 2026

Cite this page

510(k) Report. “K050184: Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050184

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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