510(k) Report

510(k) · Cleared

Cleared

Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use)

K082457510(k) AbbreviatedCleared Nov 10, 200876-day reviewClass I21 CFR 880.6250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ansell Healthcare Products, Inc. · LZA Polymer Patient Examination Glove

Cleared on Nov 10, 2008 after a 76-day review. The FDA summary names no predicate by number. 8 later devices descend from it.

Decided
Nov 10, 2008
Review
76 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2020: 1 descendant cleared2024: 2 descendants cleared2021: 1 descendant cleared2022: 1 descendant cleared2025: 3 descendants cleared20052010201520202025
  1. This deviceK082457 Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination…Ansell Healthcare Products, Inc. · 2008
  2. Descendant · cites it directly · 7 of its ownK200671 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile…Ansell Healthcare Products, LLC · 2020
  3. Descendant · 2 generations on · 2 of its ownK210401 Microflex Nitrile Patient Examination Gloves Blue Colored Tested for…Ansell Healthcare Products, LLC · 2021
  4. Descendant · 2 generations on · 1 of its ownK240080 Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with…Syntex Healthcare Products Co., Ltd. · 2024
  5. Descendant · 2 generations on · 1 of its ownK231365 Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored…Anhui Intco Medical Products Co., Ltd. · 2024
  6. Descendant · 3 generations on · 1 of its ownK212148 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue)…Ansell Healthcare Products, LLC · 2022

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2020: 12021: 12022: 12024: 22025: 3
2020high 3 (2025) · low 0 (2023)2026

Most influential descendants

Showing 5 of 8 · See all
  • K200671Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink…Ansell Healthcare Products, LLC · 2020 · cites it directly7descendants
  • K210401Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with…Ansell Healthcare Products, LLC · 2021 · 2 generations on2descendants
  • K240080Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and…Syntex Healthcare Products Co., Ltd. · 2024 · 2 generations on1descendant
  • K231365Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use…Anhui Intco Medical Products Co., Ltd. · 2024 · 2 generations on1descendant
  • K212148Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with…Ansell Healthcare Products, LLC · 2022 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K082457Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination Gloves…Ansell Healthcare Products, Inc.2008—
+1K200671Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue…Ansell Healthcare Products, LLC2020—
+2K210401Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with…Ansell Healthcare Products, LLC2021—
+2K240080Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy…Syntex Healthcare Products Co., Ltd.2024—
+2K231365Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and…Anhui Intco Medical Products Co., Ltd.2024—
+3K212148Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for…Ansell Healthcare Products, LLC2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202110
202210
202420
202530
FIG. 1 — Lineage of K082457, 2008–2025Source: 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 LZA? 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 LZA device

  1. #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 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? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K200671Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink…Ansell Healthcare Products, LLC20207

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, K200671 (Ansell Healthcare Products, LLC, 2020) has gone furthest, with 7 descendants of its own.

How does its category compare?

All LZA devices

LZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · LZA

24in 2025

2007: 212008: 182009: 282010: 312011: 262012: 332013: 202014: 272015: 202016: 302017: 442018: 222019: 252020: 302021: 1392022: 1462023: 622024: 302025: 242026 (partial year): 15
2007high 146 (2022) · low 18 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZA

110in 2025

2007: 95 days median2008: 97 days median2009: 112 days median2010: 97 days median2011: 122 days median2012: 110 days median2013: 130 days median2014: 197 days median2015: 112 days median2016: 171 days median2017: 124 days median2018: 178 days median2019: 212 days median2020: 101 days median2021: 111 days median2022: 111 days median2023: 92 days median2024: 89 days median2025: 110 days median2026 (partial year): 103 days median
2007high 212 (2019) · low 89 (2024)2026

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

Recalls per year · LZA

3so far in 2026, the most since 2007

2015: 12016: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZA

73in 2025

2007: 72008: 22009: 122010: 122011: 92012: 112013: 102014: 82015: 122016: 252017: 42018: 32019: 212020: 42021: 202022: 192023: 242024: 762025: 73
2007high 76 (2024) · low 2 (2008)2025

MAUDE reports naming product code LZA, 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
2007219507
2008189702
200928112012
20103197012
20112612209
201233110011
201320130010
20142719708
201520112112
201630171125
20174412404
20182217803
201925212021
20203010104
2021139111020
2022146111019
20236292024
20243089076
202524110073
2026151033—

What is it indicated for?

This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.

Indications for use as stated in the FDA summary.

More from Ansell Healthcare Products, Inc.

10 FDA decisions under this applicant name. See the company

  • K111139Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for UAnsell Healthcare Products, Inc. · 20113 recalls
  • K042817Micro-Touch Smooth Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use)Ansell Healthcare Products, Inc. · 2004
  • K023153Micro-Touch Next Step Powder Free Medical Examination Gloves with Aloe and GlycerolAnsell Healthcare Products, Inc. · 2002
  • K013603Modification to:Micro Touch (R) Powder Free Latex Surgical Gloves , Model Style 65Ansell Healthcare Products, Inc. · 2001
  • K013604Modification to: Ultralon (R) Powder Free Latex Surgical GlovesAnsell Healthcare Products, Inc. · 2001

Recent decisions in LZA

The LZA category page

  • K262208Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for…Yty Industry (Manjung) Sdn Bhd · 2026
  • K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and…Maxter Healthcare, Inc. · 2026
  • K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination…Top Glove Sdn. Bhd. · 2026
  • K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl…Gmp Medicare Sdn. Bhd. · 2026
  • K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth · 2026

https://510kreport.com/device/K082457 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082457: Micro-Touch Nitratex Sterile Nitrile Powder-Free Blue Examination Gloves (Chemotherapy Use).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082457

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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