510(k) · Cleared
ClearedMedical Examination Gloves (Nitrile) (XS, S, M, L, XL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Humanwell Healthcare Group Medical Supplies Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Oct 26, 2022 as substantially equivalent to K171422 (Ever Global (Vietnam) Enterprise Corp, 2018) after a 69-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it.
- Decided
- Oct 26, 2022
- Review
- 69 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K171422 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK171422 Disposable Powder Free Nitrile Examination Glove, White/ Blue/…Ever Global (Vietnam) Enterprise Corp · 2018
- This deviceK222498 Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)Humanwell Healthcare Group Medical Supplies Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK223895 Disposable Medical Nitrile Examination GlovesHebei Titans Hongsen Medical Technology Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223895Disposable Medical Nitrile Examination GlovesHebei Titans Hongsen Medical Technology Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color | Ever Global (Vietnam) Enterprise Corp | 2018 | — |
| 0 (this device) | K222498 | Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) | Humanwell Healthcare Group Medical Supplies Co., Ltd. | 2022 | — |
| +1 | K223895 | Disposable Medical Nitrile Examination Gloves | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink ColorSummary page 4…Name: Polymer Patient Examination Glove Classification: Class I Product code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital C. Predicate device: K171422 Disposable Powder Free Nitrile Examination Glove, White/Blue/ Black/ Pink Color Ever Global (Vietnam) Enterprise Corp D. Indicat… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223895 | Disposable Medical Nitrile Examination Gloves | 2023 | 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?
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Medical Examination Glove (Nitrile) 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/K222498 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222498: Medical Examination Gloves (Nitrile) (XS, S, M, L, XL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222498
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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