510(k) Report

510(k) · Cleared

Cleared

Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves

K071746510(k) TraditionalCleared Dec 13, 2007169-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 Dec 13, 2007 after a 169-day review. The FDA summary names no predicate by number. 7 later devices descend from it.

Decided
Dec 13, 2007
Review
169 days
Class
Class I
Product code
KGO
Recalls
None
Predicates
0

7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2016: 1 descendant cleared2019: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2023: 2 descendants cleared20052010201520202025
  1. This deviceK071746 Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic…Ansell Healthcare Products, LLC · 2007
  2. Descendant · cites it directly · 5 of its ownK151694 Gammex PI Hybrid Surgical GlovesAnsell Healthcare Products, LLC · 2016
  3. Descendant · 2 generations on · 2 of its ownK171047 Sterile Polyisoprene Powder Free Surgical GlovesBetter Care Plastic Technology Co., Ltd. · 2017
  4. Descendant · 2 generations on · 1 of its ownK182948 Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy…Ansell Healthcare Products, LLC · 2019
  5. Descendant · 3 generations on · 0 of its ownK231902 GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro…Ansell Healthcare · 2023
  6. Descendant · 3 generations on · 0 of its ownK230304 Polyisoprene Surgical GlovesPuyang Linshi Medical Supplies Co., Ltd. · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2016: 12017: 12018: 12019: 12021: 12023: 2
2016high 2 (2023) · low 0 (2020)2026

Most influential descendants

Showing 5 of 7 · See all
  • K151694Gammex PI Hybrid Surgical GlovesAnsell Healthcare Products, LLC · 2016 · cites it directly5descendants
  • K171047Sterile Polyisoprene Powder Free Surgical GlovesBetter Care Plastic Technology Co., Ltd. · 2017 · 2 generations on2descendants
  • K182948Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy DrugsAnsell Healthcare Products, LLC · 2019 · 2 generations on1descendant
  • K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid…Ansell Healthcare · 2023 · 3 generations on0descendants
  • K230304Polyisoprene Surgical GlovesPuyang Linshi Medical Supplies Co., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K071746Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene…Ansell Healthcare Products, LLC2007—
+1K151694Gammex PI Hybrid Surgical GlovesAnsell Healthcare Products, LLC2016—
+2K171047Sterile Polyisoprene Powder Free Surgical GlovesBetter Care Plastic Technology Co., Ltd.2017—
+2K182948Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy DrugsAnsell Healthcare Products, LLC2019—
+3K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX…Ansell Healthcare2023—
+3K230304Polyisoprene Surgical GlovesPuyang Linshi Medical Supplies Co., Ltd.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201710
201810
201910
202110
202320
FIG. 1 — Lineage of K071746, 2007–2023Source: 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?

The FDA summary names no predicate by number.

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K151694Gammex PI Hybrid Surgical GlovesAnsell Healthcare Products, LLC20165
K171375Gammex PI Breach Detect Powder Free Surgical GloveAnsell Healthcare Products, LLC20180

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, K151694 (Ansell Healthcare Products, LLC, 2016) has gone furthest, with 5 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. 2007, 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 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.

More from Ansell Healthcare Products, LLC

26 FDA decisions under this applicant name. See the company

  • K230079Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis PotentialAnsell Healthcare Products, LLC · 2023
  • K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy DrugsAnsell Healthcare Products, LLC · 2023
  • K212148Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy DrugsAnsell Healthcare Products, LLC · 2022
  • K210401Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and…Ansell Healthcare Products, LLC · 2021
  • K200671Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested forAnsell Healthcare Products, LLC · 2020

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/K071746 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071746: Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071746

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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