510(k) · Cleared
ClearedDisposable Powder Free Nitrile Examination Glove, Pink/Black Color
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ever Growth (Vietnam) Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Jan 7, 2020 as substantially equivalent to K172642 (Central Medicare Sdn Bhd, 2017) after a 272-day review. Its family tree reaches back 2 generations to 2015. 10 later devices descend from it.
- Decided
- Jan 7, 2020
- Review
- 272 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K143247 (2015). 10 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK143247 Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and…Central Medicare Sdn Bhd · 2015
- 1 generation backK172642 Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd · 2017
- This deviceK190942 Disposable Powder Free Nitrile Examination Glove, Pink/Black ColorEver Growth (Vietnam) Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK210463 Thermoplastic Elastomer (TPE) Hybrid Examination GloveXuzhou Full Sun Medical Products, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK233740 Black Nitrile Powder Free Patient Examination Glove, Non SterileW.A. Rubbermate Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK222103 Nitrile Patient Examination Gloves, Powder Free, Pink ColorShandong Yinghng Medical Products Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK222531 Synthetic Polymer Glove - Polyethylene (Black)Ur Industry Sdn Bhd · 2023
- Descendant · cites it directly · 0 of its ownK222715 Black Nitrile Powder Free Patient Examination Glove, Non SterileSafeskin Retailing (Hk) Limited · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K210463Thermoplastic Elastomer (TPE) Hybrid Examination GloveXuzhou Full Sun Medical Products, Ltd. · 2022 · cites it directly1descendant
- K233740Black Nitrile Powder Free Patient Examination Glove, Non SterileW.A. Rubbermate Co., Ltd. · 2024 · cites it directly0descendants
- K222103Nitrile Patient Examination Gloves, Powder Free, Pink ColorShandong Yinghng Medical Products Co., Ltd. · 2023 · cites it directly0descendants
- K222531Synthetic Polymer Glove - Polyethylene (Black)Ur Industry Sdn Bhd · 2023 · 2 generations on0descendants
- K222715Black Nitrile Powder Free Patient Examination Glove, Non SterileSafeskin Retailing (Hk) Limited · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K143247 | Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White… | Central Medicare Sdn Bhd | 2015 | — |
| −1 | K172642 | Orange Non Sterile Powder Free Nitrile Examination Gloves | Central Medicare Sdn Bhd | 2017 | — |
| 0 (this device) | K190942 | Disposable Powder Free Nitrile Examination Glove, Pink/Black Color | Ever Growth (Vietnam) Co., Ltd. | 2020 | — |
| +1 | K210463 | Thermoplastic Elastomer (TPE) Hybrid Examination Glove | Xuzhou Full Sun Medical Products, Ltd. | 2022 | — |
| +1 | K233740 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | W.A. Rubbermate Co., Ltd. | 2024 | — |
| +1 | K222103 | Nitrile Patient Examination Gloves, Powder Free, Pink Color | Shandong Yinghng Medical Products Co., Ltd. | 2023 | — |
| +2 | K222531 | Synthetic Polymer Glove - Polyethylene (Black) | Ur Industry Sdn Bhd | 2023 | — |
| +1 | K222715 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | Safeskin Retailing (Hk) Limited | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K172642 | Orange Non Sterile Powder Free Nitrile Examination GlovesSummary page 5…Non Sterile Powder Free Nitrile Examination Gloves Company name: Central Medicare Sdn. Bhd. 510(K) Number: K172642 5.0 Device Description: “Disposable Powder Free Nitrile Examination Glove, Pink Color” and “Disposable Powder Free Nitri… | 2017 |
What descends from it? (10)
9 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210463 | Thermoplastic Elastomer (TPE) Hybrid Examination Glove | 2022 | 1 |
| K233740 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | 2024 | 0 |
| K222103 | Nitrile Patient Examination Gloves, Powder Free, Pink Color | 2023 | 0 |
| K222715 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | 2022 | 0 |
| K221887 | Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile… | 2022 | 0 |
| K212916 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | 2022 | 0 |
| K212801 | Powder free nitrile examination glove- black, non sterile | 2022 | 0 |
| K210588 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | 2021 | 0 |
| K210706 | Nitrile 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 5 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K210463 (Xuzhou Full Sun Medical Products, Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K172642.
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?
The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is
worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is
worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190942 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190942: Disposable Powder Free Nitrile Examination Glove, Pink/Black Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190942
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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