510(k) · Cleared
ClearedChienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chienmax Vietnam Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Oct 3, 2011 as substantially equivalent to K101870 (Sunmax Vietnam Co., Ltd., 2010) and 2 other predicates after a 291-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Oct 3, 2011
- Review
- 291 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K022765 (2002). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK022765 Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp. · 2002
- 3 generations backK071072 Shanghai China Star Corp. Powder Free Blue Nitrile Patient…Shanghai China Star Corp · 2007
- 2 generations backK090336 Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient…Sunmax Enterprise Shanghai Co., Ltd. · 2009
- 1 generation backK101870 Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination GloveSunmax Vietnam Co., Ltd. · 2010
- This deviceK103675 Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination GloveChienmax Vietnam Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K022765 | Nitrile Powder-Free Examination Gloves | Allegiance Healthcare Corp. | 2002 | — |
| −3 | K071072 | Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination Glove | Shanghai China Star Corp | 2007 | — |
| −2 | K090336 | Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination… | Sunmax Enterprise Shanghai Co., Ltd. | 2009 | — |
| −1 | K101870 | Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination Glove | Sunmax Vietnam Co., Ltd. | 2010 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K101870 | Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination Glove Cleared while this submission was under review Summary page 1…on glove (21 CER 880.6250, product code LZA) 8. Predicate Devices: *Sunmax Vietnam Co. Ltd Powder free Nitrile Patient Examination Gloves. (K101870) * ULTRAWIN SODN BHD Non-Sterile Powder Free Nitrile Examination Gloves (K… | 2010 |
| * | K090828 | Non-Sterile, Powder Free Nitrile Examination GlovesSummary page 2…Patient Examination Gloves. (K101870) * ULTRAWIN SODN BHD Non-Sterile Powder Free Nitrile Examination Gloves (K 090828) * PT. MAHAKARYA INTl BUANA Powder Free Black Nitrile Examination gloves.… | 2009 |
| * | K090464 | Black Nitrile Examination Gloves, Powder Free, Non SterileSummary page 2…090828) * PT. MAHAKARYA INTl BUANA Powder Free Black Nitrile Examination gloves. (K090464) 9. Device Description: Chienmax Vietnam Co. Ltd Powder Free Blue Nitrile Patient Examinat… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K103675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103675: Chienmax Vietnam CO. LTD Powder Free Blue 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/K103675
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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