510(k) Report

510(k) · Cleared

Cleared

Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves

K022548510(k) TraditionalCleared Aug 15, 200214-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

Latexx Manufacturing Sdn.Bhd. · LZA Polymer Patient Examination Glove

Cleared on Aug 15, 2002 after a 14-day review. The FDA summary names its predicate without a number. 48 later devices descend from it.

Decided
Aug 15, 2002
Review
14 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2018: 1 descendant cleared2016: 1 descendant cleared2022: 19 descendants cleared2020: 2 descendants cleared2021: 20 descendants cleared2023: 5 descendants cleared200020052010201520202025
  1. This deviceK022548 Medtexx Blue Colour Powder-Free Nitrile Rubber Examination GlovesLatexx Manufacturing Sdn.Bhd. · 2002
  2. Descendant · cites it directly · 46 of its ownK172930 mCare Powder-free Blue Nitrile Examination GlovesMercator Medical (Thailand), Ltd. · 2018
  3. Descendant · 2 generations on · 43 of its ownK192333 Blue Nitrile Examination Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020
  4. Descendant · 3 generations on · 8 of its ownK202384 Palm Care Blue Nitrile Examination Gloves Powder FreeHi-Care Thai Gloves Co., Ltd. · 2020
  5. Descendant · 3 generations on · 6 of its ownK203191 LYDUS Nitrile Examination Gloves, Powder FreeNathan Trading Co., Ltd. · 2021
  6. Descendant · 3 generations on · 2 of its ownK211515 Nitrile Examination GlovesBeijing Reagent Latex Products Co., Ltd. · 2021

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2016: 12018: 12020: 22021: 202022: 192023: 5
2016high 20 (2021) · low 0 (2017)2026

Most influential descendants

Showing 5 of 48 · See all
  • K172930mCare Powder-free Blue Nitrile Examination GlovesMercator Medical (Thailand), Ltd. · 2018 · cites it directly46descendants
  • K192333Blue Nitrile Examination Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020 · 2 generations on43descendants
  • K202384Palm Care Blue Nitrile Examination Gloves Powder FreeHi-Care Thai Gloves Co., Ltd. · 2020 · 3 generations on8descendants
  • K203191LYDUS Nitrile Examination Gloves, Powder FreeNathan Trading Co., Ltd. · 2021 · 3 generations on6descendants
  • K211515Nitrile Examination GlovesBeijing Reagent Latex Products Co., Ltd. · 2021 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022548Medtexx Blue Colour Powder-Free Nitrile Rubber Examination GlovesLatexx Manufacturing Sdn.Bhd.2002—
+1K172930mCare Powder-free Blue Nitrile Examination GlovesMercator Medical (Thailand), Ltd.2018—
+2K192333Blue Nitrile Examination Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd.2020—
+3K202384Palm Care Blue Nitrile Examination Gloves Powder FreeHi-Care Thai Gloves Co., Ltd.2020—
+3K203191LYDUS Nitrile Examination Gloves, Powder FreeNathan Trading Co., Ltd.2021—
+3K211515Nitrile Examination GlovesBeijing Reagent Latex Products Co., Ltd.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201810
202020
2021200
2022190
202350
FIG. 1 — Lineage of K022548, 2002–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (2)

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
*—Class I patient examination glove bearing product code 80UA
Named without a submission number
—
*—Class 1 patient examination glove bearing product code 80LW
Named without a submission number
—

What descends from it? (48)

See all 48

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

NumberDeviceApplicantDecidedDescendants
K172930mCare Powder-free Blue Nitrile Examination GlovesMercator Medical (Thailand), Ltd.201846
K152479HG Pro Nitrile Powder Free Examination GlovesHealthy Glove Co., Ltd.20160

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, K172930 (Mercator Medical (Thailand), Ltd., 2018) has gone furthest, with 46 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?

Blue Colour Powder Free Nitrile Rubber Examination Gloves is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Indications for use as stated in the FDA summary.

More from Latexx Manufacturing Sdn.Bhd.

10 FDA decisions under this applicant name. See the company

  • K102189Powder Free Nitrle Examination Gloves with Chemotherapy Labeling ClaimLatexx Manufacturing Sdn.Bhd. · 2012
  • K101645Non-Chlorinated, Polymer Coated Powder Free Natural Rubber Latex Examination Gloves and Protein Labeling…Latexx Manufacturing Sdn.Bhd. · 2010
  • K034052Black Colour Powder-Free Nitrile Rubber Examination GlovesLatexx Manufacturing Sdn.Bhd. · 2004
  • K022346Cleantexx Mint Flavour Blue Colour Powder-Free Barrier Pro Copolymer Examination GlovesLatexx Manufacturing Sdn.Bhd. · 2002
  • K022102Cleantexx Powderfree Barrier-Pro Synthetic Butadiene Copolymer Examination Gloves, Blue ColourLatexx Manufacturing Sdn.Bhd. · 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/K022548 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022548: Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022548

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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