510(k) Report

510(k) · Cleared

Cleared

Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating

K102500510(k) TraditionalCleared Nov 4, 201064-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

Cardinal Health, Inc. · KGO Surgeon'S Gloves

Cleared on Nov 4, 2010 as substantially equivalent to K013302 (Allegiance Healthcare Corp., 2001) after a 64-day review. Its family tree reaches back 1 generation to 2001. 7 later devices descend from it.

Decided
Nov 4, 2010
Review
64 days
Class
Class I
Product code
KGO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K013302 (2001). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2012: 1 descendant cleared2016: 1 descendant cleared2014: 1 descendant cleared2017: 2 descendants cleared2023: 1 descendant clearedK013302 · Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with Chemotherapy Drugs Labeling Claim · Allegiance Healthcare Corp. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K013302 · Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with Chemotherapy Drugs Labeling Claim · Allegiance Healthcare Corp. · 20010
  1. Root · 1 generation backK013302 Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested…Allegiance Healthcare Corp. · 2001
  2. This deviceK102500 Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health, Inc. · 2010
  3. Descendant · cites it directly · 3 of its ownK122557 Motex Powder-Free Nitrile Surgical GlovesShanghai Motex Healthcare Co., Ltd. · 2013
  4. Descendant · 2 generations on · 2 of its ownK140989 Powder Free Nitrile Surgical Gloves, White Color (Brand Name…Hebei Hongsen Plastics Technology Co, Ltd. · 2014
  5. Descendant · cites it directly · 2 of its ownK113707 Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health-Medical Products and Services · 2012 · Recalled
  6. Descendant · 3 generations on · 1 of its ownK170515 Sterile Nitrile Surgical Gloves, Powder-freePrimus Gloves Pvt Limited · 2017
  7. Descendant · 2 generations on · 1 of its ownK153316 Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with…Cardinal Health, Inc. · 2016

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 12016: 12017: 22023: 1
2012high 2 (2017) · low 0 (2015)2026

Most influential descendants

Showing 5 of 7 · See all
  • K122557Motex Powder-Free Nitrile Surgical GlovesShanghai Motex Healthcare Co., Ltd. · 2013 · cites it directly3descendants
  • K140989Powder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine)Hebei Hongsen Plastics Technology Co, Ltd. · 2014 · 2 generations on2descendants
  • K113707Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health-Medical Products and Services · 2012 · cites it directly2descendants
  • K170515Sterile Nitrile Surgical Gloves, Powder-freePrimus Gloves Pvt Limited · 2017 · 3 generations on1descendant
  • K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and…Cardinal Health, Inc. · 2016 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K013302Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use…Allegiance Healthcare Corp.2001—
0 (this device)K102500Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health, Inc.2010—
+1K122557Motex Powder-Free Nitrile Surgical GlovesShanghai Motex Healthcare Co., Ltd.2013—
+2K140989Powder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine)Hebei Hongsen Plastics Technology Co, Ltd.2014—
+1K113707Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health-Medical Products and Services20128
+3K170515Sterile Nitrile Surgical Gloves, Powder-freePrimus Gloves Pvt Limited2017—
+2K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile…Cardinal Health, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201410
201610
201720
202310
FIG. 1 — Lineage of K102500, 2001–2023Source: 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 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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K013302Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with…
Summary page 1
…care facilities. Predicate Devices: Sterile Synthetic Neoprene Powder-Free Surgical Gloves previously cleared under 5 10(k) K0 13 302 (product code KGO); Cardinal Health, Inc. Premarket Notification Submission - Traditional 51 0(k)…
Allegiance Healthcare Corp.2001—

Also cleared against K013302: 5 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K122557Motex Powder-Free Nitrile Surgical GlovesShanghai Motex Healthcare Co., Ltd.20133
K113707Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health-Medical Products and Services20122

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, K122557 (Shanghai Motex Healthcare Co., Ltd., 2013) has gone furthest, with 3 descendants of its own.
  • 5 other devices also cite its predicate K013302.

How does its category compare?

All KGO devices

KGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

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?

These powder-free sterile surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.

Indications for use as stated in the FDA summary.

Also cleared against K013302

5 other devices cite the same predicate.

  • K140477Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove SeriesMolnlycke Health Care Us, LLC · 2015
  • K113707Sterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health-Medical Products and Services · 20128 recalls
  • K111139Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for UAnsell Healthcare Products, Inc. · 20113 recalls
  • K103714Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with ChemotheraAnsell Healthcare Products, LLC · 2011
  • K110272Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy DrugCardinal Health, Inc. · 20111 recall

More from Cardinal Health, Inc.

26 FDA decisions under this applicant name. See the company

  • K170198Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy…Cardinal Health, Inc. · 2017
  • K160411Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera CoatingCardinal Health, Inc. · 2016
  • K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingCardinal Health, Inc. · 2016
  • K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with…Cardinal Health, Inc. · 2016
  • K122696Powder-Free Nitrile Examination Gloves (Cool Blue)Cardinal Health, Inc. · 2013

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/K102500 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102500: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102500

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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