510(k) Report

510(k) · Cleared

Cleared

Blue Nitrile Examination Gloves Powder Free

K192333510(k) AbbreviatedCleared Jan 24, 2020150-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

Jr Engineering & Medical Technologies (M) Sdn. Bhd. · LZA Polymer Patient Examination Glove

Cleared on Jan 24, 2020 as substantially equivalent to K172930 (Mercator Medical (Thailand), Ltd., 2018) after a 150-day review. Its family tree reaches back 2 generations to 2002. 43 later devices descend from it.

Decided
Jan 24, 2020
Review
150 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K022548 (2002). 43 later devices descend from it, 24 citing it directly.

Descendants, by year cleared 2022: 17 descendants cleared2021: 20 descendants cleared2020: 1 descendant cleared2023: 5 descendants clearedK022548 · Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves · Latexx Manufacturing Sdn.Bhd. · 2002K172930 · mCare Powder-free Blue Nitrile Examination Gloves · Mercator Medical (Thailand), Ltd. · 2018200020052010201520202025
Descendants, by generation 1 generation forward: 24 descendants2 generations forward: 18 descendants3 generations forward: 1 descendant K172930 · mCare Powder-free Blue Nitrile Examination Gloves · Mercator Medical (Thailand), Ltd. · 2018K022548 · Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves · Latexx Manufacturing Sdn.Bhd. · 20020
  1. Root · 2 generations backK022548 Medtexx Blue Colour Powder-Free Nitrile Rubber Examination GlovesLatexx Manufacturing Sdn.Bhd. · 2002
  2. 1 generation backK172930 mCare Powder-free Blue Nitrile Examination GlovesMercator Medical (Thailand), Ltd. · 2018
  3. This deviceK192333 Blue Nitrile Examination Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020
  4. Descendant · cites it directly · 8 of its ownK202384 Palm Care Blue Nitrile Examination Gloves Powder FreeHi-Care Thai Gloves Co., Ltd. · 2020
  5. Descendant · cites it directly · 6 of its ownK203191 LYDUS Nitrile Examination Gloves, Powder FreeNathan Trading Co., Ltd. · 2021
  6. Descendant · cites it directly · 2 of its ownK211515 Nitrile Examination GlovesBeijing Reagent Latex Products Co., Ltd. · 2021
  7. Descendant · cites it directly · 1 of its ownK221169 JR MEDIC Nitrile Examination Gloves Powder Free- BlackJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022
  8. Descendant · 2 generations on · 1 of its ownK213739 Nitrile Examination GlovesHangzhou Runheng Medical Co., Ltd. · 2022

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2020: 12021: 202022: 172023: 5
2020high 20 (2021) · low 0 (2024)2026

Most influential descendants

Showing 5 of 43 · See all
  • K202384Palm Care Blue Nitrile Examination Gloves Powder FreeHi-Care Thai Gloves Co., Ltd. · 2020 · cites it directly8descendants
  • K203191LYDUS Nitrile Examination Gloves, Powder FreeNathan Trading Co., Ltd. · 2021 · cites it directly6descendants
  • K211515Nitrile Examination GlovesBeijing Reagent Latex Products Co., Ltd. · 2021 · cites it directly2descendants
  • K221169JR MEDIC Nitrile Examination Gloves Powder Free- BlackJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022 · cites it directly1descendant
  • K213739Nitrile Examination GlovesHangzhou Runheng Medical Co., Ltd. · 2022 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K022548Medtexx Blue Colour Powder-Free Nitrile Rubber Examination GlovesLatexx Manufacturing Sdn.Bhd.2002—
−1K172930mCare Powder-free Blue Nitrile Examination GlovesMercator Medical (Thailand), Ltd.2018—
0 (this device)K192333Blue Nitrile Examination Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd.2020—
+1K202384Palm Care Blue Nitrile Examination Gloves Powder FreeHi-Care Thai Gloves Co., Ltd.2020—
+1K203191LYDUS Nitrile Examination Gloves, Powder FreeNathan Trading Co., Ltd.2021—
+1K211515Nitrile Examination GlovesBeijing Reagent Latex Products Co., Ltd.2021—
+1K221169JR MEDIC Nitrile Examination Gloves Powder Free- BlackJr Engineering & Medical Technologies (M) Sdn. Bhd.2022—
+2K213739Nitrile Examination GlovesHangzhou Runheng Medical Co., Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
2021200
2022170
202350
FIG. 1 — Lineage of K192333, 2002–2023Source: 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 K203593 Patient Examination Glovesscore 34.6 · 3 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
*K172930mCare Powder-free Blue Nitrile Examination Gloves
Summary page 4
…MCare Blue Nitrile Examination Gloves Powder-free 510( k) Number K172930 Regulatory Class 1 Product code LZA D. DESCRIPTION OF THE…
Mercator Medical (Thailand), Ltd.2018—

Also cleared against K172930: 2 other devices →

What descends from it? (43)

See all 43

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

NumberDeviceApplicantDecidedDescendants
K202384Palm Care Blue Nitrile Examination Gloves Powder FreeHi-Care Thai Gloves Co., Ltd.20208
K203191LYDUS Nitrile Examination Gloves, Powder FreeNathan Trading Co., Ltd.20216
K211515Nitrile Examination GlovesBeijing Reagent Latex Products Co., Ltd.20212
K221169JR MEDIC Nitrile Examination Gloves Powder Free- BlackJr Engineering & Medical Technologies (M) Sdn. Bhd.20221
K213016ATM GlovePhu Duc Huy Production Trading Services Corporation20211
K210366Blue Nitrile Powder Free Patient Examination Glove, Non SterileOnetexx Sdn Bhd20211
K230601Blue Nitrile Examination Gloves Powder FreeLatrile Gloves Private Limited20230
K222720Blue Nitrile Powder Free Patient Examination Glove, Non SterileSafeskin Retailing (Hk) Limited20220
K222349JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)Jr Engineering & Medical Technologies (M) Sdn. Bhd.20220
K221877Powder-Free Nitrile Examination Glove, Non-SterileGoodgloves Industries Sdn Bhd20220

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?

  • The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 15.7 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K202384 (Hi-Care Thai Gloves Co., Ltd., 2020) has gone furthest, with 8 descendants of its own.
  • 2 other devices also cite its predicate K172930.

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. 2020, 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?

Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner.

Indications for use as stated in the FDA summary.

Also cleared against K172930

2 other devices cite the same predicate.

  • K213678Powder Free Blue Nitrile Examination GlovesLienteh Technology Sdn Bhd · 2022
  • K213107Powder Free Blue Nitrile Examination GlovesNovid Ppe Sdn. Bhd. · 2022

More from Jr Engineering & Medical Technologies…

10 FDA decisions under this applicant name. See the company

  • K222350Sterile Nitrile Surgical Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2023
  • K221626Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl…Jr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022
  • K222348JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022
  • K221169JR MEDIC Nitrile Examination Gloves Powder Free- BlackJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022
  • K222349JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)Jr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022

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/K192333 · printed Nov 5, 2026

Cite this page

510(k) Report. “K192333: Blue Nitrile Examination Gloves Powder Free.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192333

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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