510(k) · Cleared
ClearedOrange Non Sterile Powder Free Nitrile Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Central Medicare Sdn Bhd · LZC Medical Glove, Specialty
Cleared on Nov 28, 2017 as substantially equivalent to K143247 (Central Medicare Sdn Bhd, 2015) after an 88-day review. Its family tree reaches back 1 generation to 2015. 12 later devices descend from it.
- Decided
- Nov 28, 2017
- Review
- 88 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K143247 (2015). 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK143247 Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and…Central Medicare Sdn Bhd · 2015
- This deviceK172642 Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd · 2017
- Descendant · cites it directly · 10 of its ownK190942 Disposable Powder Free Nitrile Examination Glove, Pink/Black ColorEver Growth (Vietnam) Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK210463 Thermoplastic Elastomer (TPE) Hybrid Examination GloveXuzhou Full Sun Medical Products, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK233740 Black Nitrile Powder Free Patient Examination Glove, Non SterileW.A. Rubbermate Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK222103 Nitrile Patient Examination Gloves, Powder Free, Pink ColorShandong Yinghng Medical Products Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK222531 Synthetic Polymer Glove - Polyethylene (Black)Ur Industry Sdn Bhd · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K190942Disposable Powder Free Nitrile Examination Glove, Pink/Black ColorEver Growth (Vietnam) Co., Ltd. · 2020 · cites it directly10descendants
- K210463Thermoplastic Elastomer (TPE) Hybrid Examination GloveXuzhou Full Sun Medical Products, Ltd. · 2022 · 2 generations on1descendant
- K233740Black Nitrile Powder Free Patient Examination Glove, Non SterileW.A. Rubbermate Co., Ltd. · 2024 · 2 generations on0descendants
- K222103Nitrile Patient Examination Gloves, Powder Free, Pink ColorShandong Yinghng Medical Products Co., Ltd. · 2023 · 2 generations on0descendants
- K222531Synthetic Polymer Glove - Polyethylene (Black)Ur Industry Sdn Bhd · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K143247 | Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White… | Central Medicare Sdn Bhd | 2015 | — |
| 0 (this device) | K172642 | Orange Non Sterile Powder Free Nitrile Examination Gloves | Central Medicare Sdn Bhd | 2017 | — |
| +1 | K190942 | Disposable Powder Free Nitrile Examination Glove, Pink/Black Color | Ever Growth (Vietnam) Co., Ltd. | 2020 | — |
| +2 | K210463 | Thermoplastic Elastomer (TPE) Hybrid Examination Glove | Xuzhou Full Sun Medical Products, Ltd. | 2022 | — |
| +2 | K233740 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | W.A. Rubbermate Co., Ltd. | 2024 | — |
| +2 | K222103 | Nitrile Patient Examination Gloves, Powder Free, Pink Color | Shandong Yinghng Medical Products Co., Ltd. | 2023 | — |
| +3 | K222531 | Synthetic Polymer Glove - Polyethylene (Black) | Ur Industry Sdn Bhd | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 3 | 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 LZC? 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 LZC device
- #1 K201390 Medline Powder-Free Light Blue Nitrile Exam…score 19.2 · 5 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 |
|---|---|---|---|
| * | K143247 | Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)Summary page 4…and White Colored) 510k Number K143247 Product Code LZA LZA Same Regulat… | 2015 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K190942 (Ever Growth (Vietnam) Co., Ltd., 2020) has gone furthest, with 10 descendants of its own.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LZC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZC
85in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZC
10in 2025
MAUDE reports naming product code LZC, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 166 | 1 | 0 |
| 2009 | 5 | 253 | 0 | 1 |
| 2010 | 5 | 68 | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 4 | 149 | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 258 | 0 | 5 |
| 2017 | 6 | 121 | 0 | 7 |
| 2018 | 6 | 105 | 0 | 6 |
| 2019 | 7 | 200 | 0 | 8 |
| 2020 | 3 | 167 | 0 | 1 |
| 2021 | 3 | 94 | 1 | 2 |
| 2022 | 7 | 85 | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Orange Non Sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172642: Orange Non Sterile Powder Free Nitrile Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172642
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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