510(k) · Cleared
ClearedSunmax Vietnam CO. LTD Powder Free White Nitrile Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunmax Vietnam Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Dec 20, 2010 as substantially equivalent to K090336 (Sunmax Enterprise Shanghai Co., Ltd., 2009) and 2 other predicates after a 167-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it.
- Decided
- Dec 20, 2010
- Review
- 167 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K022765 (2002). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK022765 Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp. · 2002
- 2 generations backK071072 Shanghai China Star Corp. Powder Free Blue Nitrile Patient…Shanghai China Star Corp · 2007
- 1 generation backK090336 Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient…Sunmax Enterprise Shanghai Co., Ltd. · 2009
- This deviceK101870 Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination GloveSunmax Vietnam Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK103675 Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination GloveChienmax Vietnam Co., Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K103675Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination GloveChienmax Vietnam Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022765 | Nitrile Powder-Free Examination Gloves | Allegiance Healthcare Corp. | 2002 | — |
| −2 | K071072 | Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination Glove | Shanghai China Star Corp | 2007 | — |
| −1 | K090336 | Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination… | Sunmax Enterprise Shanghai Co., Ltd. | 2009 | — |
| 0 (this device) | K101870 | Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination Glove | Sunmax Vietnam Co., Ltd. | 2010 | — |
| +1 | K103675 | Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination Glove | Chienmax Vietnam Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K090336 | Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested…Summary page 3…with chemotherapy drugs. ___________ __________(K090336) Product Code LZA LZAILZC LZA LZA Intended Use A patient A p… | 2009 |
| * | K090828 | Non-Sterile, Powder Free Nitrile Examination GlovesSummary page 3…tion Black Nitrile Glove Patient Gloves Examination (New Examination (K 090828) gloves. Device) Glove tested (K(090464)… | 2009 |
| * | K090464 | Black Nitrile Examination Gloves, Powder Free, Non SterileSummary page 3…mination (New Examination (K 090828) gloves. Device) Glove tested (K(090464) with chemotherapy… | 2009 |
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 |
|---|---|---|---|
| K103675 | Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination Glove | 2011 | 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 8 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K103675 (Chienmax Vietnam Co., Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K090336.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101870 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101870: Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101870
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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