510(k) Report

510(k) · Cleared

Cleared

Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis

K232461510(k) TraditionalCleared Nov 14, 202391-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

Kossan International Sdn Bhd · LZA Polymer Patient Examination Glove

Cleared on Nov 14, 2023 after a 91-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Nov 14, 2023
Review
91 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K232461Source: FDA 510(k) database · 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 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
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

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.

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. 2023, 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?

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in…

Read the full statement (259 words)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes

Pink Orange Blue Black

Carmustine (BCNU) (3.3 mg/ml) 12.4 11.7 10.1 14.4

Cisplatin (1.0 mg/ml) >240 >240 >240 >240

Cyclophosphamide (Cytoxan) (20.0 mg/ml) >240 >240 >240 >240

Cytarabine(100 mg/ml) >240 Not tested >240 >240

Dacarbazine (DTIC) (10.0 mg/ml) >240 >240 >240 >240

Doxorubicin Hydrochloride (2.0 mg/ml) >240 >240 >240 >240

Etoposide (20.0 mg/ml) >240 >240 >240 >240

Fluorouracil (50.0 mg/ml) >240 >240 >240 >240

lfosfamide (50.0 mg/ml) >240 Not Tested >240 >240

Methotrexate (25.0 mg/ml) >240 Not Tested >240 >240

Mitomycin C (0.5 mg/ml) >240 Not Tested >240 >240

Mitoxantrone (2.0 mg/ml) >240 Not Tested >240 >240

Paclitaxel (Taxol) (6.0 mg/ml) >240 >240 >240 >240

Thiotepa (10.0 mg/ml) 43.1 43.2 30.2 29.2

Vincristine Sulfate (1.0 mg/ml) >240 Not Tested >240 >240

Please note that Carmustine (BCNU) and Thiotepa has low permeation times.

Warning: Do Not Use with Carmustine (BCNU) and Thiotepa

Opioid Drug and Concentration Minimum Breakthrough Detection Time in Minutes

Pink Orange Blue Black

Fentanyl Citrate Injection (100 mcg/2ml) >240 >240 >240 >240

Xylazine HCI (100 mg/ml) Not Tested >240 >240 >240

Simulated Gastric Acid Minimum Breakthrough Detection Time in Minutes

Pink Orange Blue Black

Simulated Gastric Acid >240 >240 >240 >240

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

More from Kossan International Sdn Bhd

13 FDA decisions under this applicant name. See the company

  • K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR…Kossan International Sdn Bhd · 2026
  • K252549Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with…Kossan International Sdn Bhd · 2026
  • K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim…Kossan International Sdn Bhd · 2023
  • K191800Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile…Kossan International Sdn Bhd · 2019
  • K190606Powder Free Nitrile Patient Examination Glove, Black Colored, Non-SterileKossan International Sdn Bhd · 2019

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/K232461 · printed Nov 6, 2026

Cite this page

510(k) Report. “K232461: Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232461

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026