510(k) Report

510(k) · Cleared

Cleared

Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White).

K090412510(k) TraditionalCleared Jun 1, 2009103-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

Gx Corporation Sdn Bhd · LZA Polymer Patient Examination Glove

Cleared on Jun 1, 2009 after a 103-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.

Decided
Jun 1, 2009
Review
103 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2016: 3 descendants cleared2018: 1 descendant cleared2017: 2 descendants cleared2019: 1 descendant cleared20052010201520202025
  1. This deviceK090412 Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White).Gx Corporation Sdn Bhd · 2009
  2. Descendant · cites it directly · 4 of its ownK151750 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2016
  3. Descendant · 2 generations on · 1 of its ownK161215 Brightway Brand Nitrile Examination Gloves, Powder Free…Brightway Holdings Sdn. Bhd. · 2016
  4. Descendant · cites it directly · 1 of its ownK151824 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2016
  5. Descendant · 2 generations on · 0 of its ownK183441 Powder-free Nitrile Patient Examination Glove, Green Colored…Semperit Investments Asia Pte, Ltd. · 2019
  6. Descendant · 2 generations on · 0 of its ownK172864 Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for…Maxter Glove Manufacturing Sdn Bhd · 2018

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2016: 32017: 22018: 12019: 1
2016high 3 (2016) · low 0 (2020)2026

Most influential descendants

Showing 5 of 7 · See all
  • K151750Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free…Kossan International Sdn Bhd · 2016 · cites it directly4descendants
  • K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use…Brightway Holdings Sdn. Bhd. · 2016 · 2 generations on1descendant
  • K151824Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis…Kossan International Sdn Bhd · 2016 · cites it directly1descendant
  • K183441Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low…Semperit Investments Asia Pte, Ltd. · 2019 · 2 generations on0descendants
  • K172864Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy…Maxter Glove Manufacturing Sdn Bhd · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K090412Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White).Gx Corporation Sdn Bhd2009—
+1K151750Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile…Kossan International Sdn Bhd2016—
+2K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey]…Brightway Holdings Sdn. Bhd.2016—
+1K151824Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low…Kossan International Sdn Bhd2016—
+2K183441Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low…Semperit Investments Asia Pte, Ltd.2019—
+2K172864Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with…Maxter Glove Manufacturing Sdn Bhd2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201630
201720
201810
201910
FIG. 1 — Lineage of K090412, 2009–2019Source: 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 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
Get a 510(k) Report

What was it cleared against?

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

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K151750Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free…Kossan International Sdn Bhd20164
K151824Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis…Kossan International Sdn Bhd20161

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, K151750 (Kossan International Sdn Bhd, 2016) has gone furthest, with 4 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. 2009, 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 glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This glove is tested for use with Dacarbazine (DTIC), Mitomycin C, Methotrexate, Cyclophosphamide (Cytoxan), Mitoxantrone, Doxorubicin Hydrochloride, Ifosfamide (Ifex), 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel (taxol), Vincristine Sulfate

Warning: Not Recommended For Use With Carmustine and Thio-Tepa

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

More from Gx Corporation Sdn Bhd

18 FDA decisions under this applicant name. See the company

  • K200915Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy DrugsGx Corporation Sdn Bhd · 2021
  • K183354Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl CitrateGx Corporation Sdn Bhd · 2019
  • K111328Powder Free Nitrile Examination GlovesGx Corporation Sdn Bhd · 2011
  • K102074Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, Blue (SG)Gx Corporation Sdn Bhd · 2010
  • K101828Powder Free Latex Examination Gloves (18 ML), Blue Tested for Use with Chemotherapy DrugsGx Corporation Sdn Bhd · 2010

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/K090412 · printed Nov 5, 2026

Cite this page

510(k) Report. “K090412: Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White)..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090412

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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