510(k) · Cleared
ClearedPalm Care Blue Nitrile Examination Gloves Powder Free
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hi-Care Thai Gloves Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Dec 2, 2020 as substantially equivalent to K192333 (Jr Engineering & Medical Technologies (M) Sdn. Bhd., 2020) after a 104-day review. Its family tree reaches back 3 generations to 2002. 8 later devices descend from it.
- Decided
- Dec 2, 2020
- Review
- 104 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K022548 (2002). 8 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK022548 Medtexx Blue Colour Powder-Free Nitrile Rubber Examination GlovesLatexx Manufacturing Sdn.Bhd. · 2002
- 2 generations backK172930 mCare Powder-free Blue Nitrile Examination GlovesMercator Medical (Thailand), Ltd. · 2018
- 1 generation backK192333 Blue Nitrile Examination Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020
- This deviceK202384 Palm Care Blue Nitrile Examination Gloves Powder FreeHi-Care Thai Gloves Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK230958 First Glove Blue Nitrile Examination Gloves Powder FreeFirst Glove Sdn. Bhd. · 2023
- Descendant · cites it directly · 0 of its ownK212629 PP Care Nitrile Examination GlovesEg Group Product and Services Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK213500 TMG Nitrile Powder Free Examination GloveThai Medical Glove Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK213075 Goody Gloves, Wincare, TBG GlovesThai Rubber Gloves Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK211624 USA Gloves Nitrile Powder Free Exam GlovesUsa Gloves · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K230958First Glove Blue Nitrile Examination Gloves Powder FreeFirst Glove Sdn. Bhd. · 2023 · cites it directly0descendants
- K212629PP Care Nitrile Examination GlovesEg Group Product and Services Co., Ltd. · 2022 · cites it directly0descendants
- K213500TMG Nitrile Powder Free Examination GloveThai Medical Glove Co., Ltd. · 2022 · cites it directly0descendants
- K213075Goody Gloves, Wincare, TBG GlovesThai Rubber Gloves Co., Ltd. · 2022 · cites it directly0descendants
- K211624USA Gloves Nitrile Powder Free Exam GlovesUsa Gloves · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022548 | Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves | Latexx Manufacturing Sdn.Bhd. | 2002 | — |
| −2 | K172930 | mCare Powder-free Blue Nitrile Examination Gloves | Mercator Medical (Thailand), Ltd. | 2018 | — |
| −1 | K192333 | Blue Nitrile Examination Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2020 | — |
| 0 (this device) | K202384 | Palm Care Blue Nitrile Examination Gloves Powder Free | Hi-Care Thai Gloves Co., Ltd. | 2020 | — |
| +1 | K230958 | First Glove Blue Nitrile Examination Gloves Powder Free | First Glove Sdn. Bhd. | 2023 | — |
| +1 | K212629 | PP Care Nitrile Examination Gloves | Eg Group Product and Services Co., Ltd. | 2022 | — |
| +1 | K213500 | TMG Nitrile Powder Free Examination Glove | Thai Medical Glove Co., Ltd. | 2022 | — |
| +1 | K213075 | Goody Gloves, Wincare, TBG Gloves | Thai Rubber Gloves Co., Ltd. | 2022 | — |
| +1 | K211624 | USA Gloves Nitrile Powder Free Exam Gloves | Usa Gloves | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
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 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192333 | Blue Nitrile Examination Gloves Powder FreeSummary page 4…e JR Engineering & Medical Technologies (M) SDN.BHD. 510(k) Number K192333 Regulatory Class 1 Product code LZA D. DESCRIPTION OF THE DEVICE:… | 2020 |
What descends from it? (8)
8 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230958 | First Glove Blue Nitrile Examination Gloves Powder Free | 2023 | 0 |
| K212629 | PP Care Nitrile Examination Gloves | 2022 | 0 |
| K213500 | TMG Nitrile Powder Free Examination Glove | 2022 | 0 |
| K213075 | Goody Gloves, Wincare, TBG Gloves | 2022 | 0 |
| K211624 | USA Gloves Nitrile Powder Free Exam Gloves | 2021 | 0 |
| K212850 | ComfortPro Blue Nitrile Examination Gloves Powder Free | 2021 | 0 |
| K210249 | Best Glove-Nitrile Powder Free Examination Glove | 2021 | 0 |
| K211374 | Proclean - Nitrile Powder Free Examination Gloves | 2021 | 0 |
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 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K230958 (First Glove Sdn. Bhd., 2023) has gone furthest, with 0 descendants of its own.
- 23 other devices also cite its predicate K192333.
How does its category compare?
All LZA devicesLZA 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
2026 to Oct 25, outlined.
Median 510(k) review, days · LZA
110in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZA
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZA
73in 2025
MAUDE reports naming product code LZA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 95 | 0 | 7 |
| 2008 | 18 | 97 | 0 | 2 |
| 2009 | 28 | 112 | 0 | 12 |
| 2010 | 31 | 97 | 0 | 12 |
| 2011 | 26 | 122 | 0 | 9 |
| 2012 | 33 | 110 | 0 | 11 |
| 2013 | 20 | 130 | 0 | 10 |
| 2014 | 27 | 197 | 0 | 8 |
| 2015 | 20 | 112 | 1 | 12 |
| 2016 | 30 | 171 | 1 | 25 |
| 2017 | 44 | 124 | 0 | 4 |
| 2018 | 22 | 178 | 0 | 3 |
| 2019 | 25 | 212 | 0 | 21 |
| 2020 | 30 | 101 | 0 | 4 |
| 2021 | 139 | 111 | 0 | 20 |
| 2022 | 146 | 111 | 0 | 19 |
| 2023 | 62 | 92 | 0 | 24 |
| 2024 | 30 | 89 | 0 | 76 |
| 2025 | 24 | 110 | 0 | 73 |
| 2026 | 15 | 103 | 3 | — |
What is it indicated for?
Blue Nitrile Examination Gloves Powder Free is disposable devices intended for medical purpose that are worn on the examiner’s hand to prevent contamination between patient and examiner.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202384: Palm Care Blue Nitrile Examination Gloves Powder Free.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202384
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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