510(k) Report

510(k) · Cleared

Cleared

Nitrile Powder-Free Examination Gloves

K022765510(k) TraditionalCleared Oct 11, 200252-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

Allegiance Healthcare Corp. · LZA Polymer Patient Examination Glove

Cleared on Oct 11, 2002 after a 52-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.

Decided
Oct 11, 2002
Review
52 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
0

19 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2010: 4 descendants cleared2007: 1 descendant cleared2011: 2 descendants cleared2012: 1 descendant cleared2009: 1 descendant cleared2024: 2 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2016: 2 descendants cleared2021: 1 descendant cleared2020: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK022765 Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp. · 2002
  2. Descendant · cites it directly · 7 of its ownK110921 Nitrile Powder-Free Examination Gloves Tested for Use with…Cardinal Health, Inc. · 2011
  3. Descendant · 2 generations on · 6 of its ownK141623 Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug…Eco Medi Glove Sdn. Bhd. · 2014
  4. Descendant · cites it directly · 6 of its ownK071072 Shanghai China Star Corp. Powder Free Blue Nitrile Patient…Shanghai China Star Corp · 2007
  5. Descendant · 2 generations on · 5 of its ownK090336 Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient…Sunmax Enterprise Shanghai Co., Ltd. · 2009
  6. Descendant · 3 generations on · 3 of its ownK152542 Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis…Riverstone Resources Sdn Bhd · 2015

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12010: 42011: 22012: 12013: 12014: 12015: 12016: 22018: 12020: 12021: 12024: 2
2007high 4 (2010) · low 0 (2008)2026

Most influential descendants

Showing 5 of 19 · See all
  • K110921Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy DrugsCardinal Health, Inc. · 2011 · cites it directly7descendants
  • K141623Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling ClaimEco Medi Glove Sdn. Bhd. · 2014 · 2 generations on6descendants
  • K071072Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination GloveShanghai China Star Corp · 2007 · cites it directly6descendants
  • K090336Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested…Sunmax Enterprise Shanghai Co., Ltd. · 2009 · 2 generations on5descendants
  • K152542Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and…Riverstone Resources Sdn Bhd · 2015 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022765Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp.2002—
+1K110921Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy DrugsCardinal Health, Inc.2011—
+2K141623Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling ClaimEco Medi Glove Sdn. Bhd.2014—
+1K071072Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination GloveShanghai China Star Corp2007—
+2K090336Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination…Sunmax Enterprise Shanghai Co., Ltd.2009—
+3K152542Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential…Riverstone Resources Sdn Bhd2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201040
201120
201210
201310
201410
201510
201620
201810
202010
202110
202420
FIG. 1 — Lineage of K022765, 2002–2024Source: 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? (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
*—Flexam Nitrile T Ambi Examination Gloves
Named without a submission number
—

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K110921Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy DrugsCardinal Health, Inc.20117
K071072Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination GloveShanghai China Star Corp20076
K103249Nitrile Cornflower Blue Powder-Free Examination Gloves with Tested for Use with…Cardinal Health, Inc.20102
K102189Powder Free Nitrle Examination Gloves with Chemotherapy Labeling ClaimLatexx Manufacturing Sdn.Bhd.20120

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, K110921 (Cardinal Health, Inc., 2011) 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.

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?

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.

Indications for use as stated in the FDA summary.

More from Allegiance Healthcare Corp.

63 FDA decisions under this applicant name. See the company

  • K023673Airlife Demand Nasal CannulaAllegiance Healthcare Corp. · 2003
  • K023419Trilaminate Drapes/TiburonAllegiance Healthcare Corp. · 2003
  • K024120Modification to Temno Biopsy NeedlesAllegiance Healthcare Corp. · 2003
  • K024292Modification to Positive Touch Powder-Free Latex Examination Gloves with Protein and Chemotherapy Labeling…Allegiance Healthcare Corp. · 2003
  • K024102Dental Powder-Free Latex Examination Gloves with Protein Labeling ClaimAllegiance Healthcare Corp. · 2002

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/K022765 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022765: Nitrile Powder-Free Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022765

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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