510(k) · Cleared
ClearedSunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunmax Enterprise Shanghai Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Jul 1, 2009 as substantially equivalent to K071072 (Shanghai China Star Corp, 2007) and 1 other predicate after a 141-day review. Its family tree reaches back 2 generations to 2002. 5 later devices descend from it.
- Decided
- Jul 1, 2009
- Review
- 141 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022765 (2002). 3 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK022765 Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp. · 2002
- 1 generation backK071072 Shanghai China Star Corp. Powder Free Blue Nitrile Patient…Shanghai China Star Corp · 2007
- This deviceK090336 Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient…Sunmax Enterprise Shanghai Co., Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK102593 Synthetic, Powder-Free Nitrile ExaminationZibo Yinghao Medical Products Co., Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK101870 Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination GloveSunmax Vietnam Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK211667 Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)Changzhou Universal Medical Equipment Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK103675 Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination GloveChienmax Vietnam Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK101943 Synthetic, Powder-Free Nitrile Examination GlovesTangshan Jiteng Plastic Products Co., Ltd. · 2010
Most influential descendants
Showing 5 of 5 · See all- K102593Synthetic, Powder-Free Nitrile ExaminationZibo Yinghao Medical Products Co., Ltd. · 2010 · cites it directly1descendant
- K101870Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination GloveSunmax Vietnam Co., Ltd. · 2010 · cites it directly1descendant
- K211667Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)Changzhou Universal Medical Equipment Co., Ltd. · 2021 · 2 generations on0descendants
- K103675Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination GloveChienmax Vietnam Co., Ltd. · 2011 · 2 generations on0descendants
- K101943Synthetic, Powder-Free Nitrile Examination GlovesTangshan Jiteng Plastic Products Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022765 | Nitrile Powder-Free Examination Gloves | Allegiance Healthcare Corp. | 2002 | — |
| −1 | K071072 | Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination Glove | Shanghai China Star Corp | 2007 | — |
| 0 (this device) | K090336 | Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination… | Sunmax Enterprise Shanghai Co., Ltd. | 2009 | — |
| +1 | K102593 | Synthetic, Powder-Free Nitrile Examination | Zibo Yinghao Medical Products Co., Ltd. | 2010 | — |
| +1 | K101870 | Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination Glove | Sunmax Vietnam Co., Ltd. | 2010 | — |
| +2 | K211667 | Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) | Changzhou Universal Medical Equipment Co., Ltd. | 2021 | — |
| +2 | K103675 | Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination Glove | Chienmax Vietnam Co., Ltd. | 2011 | — |
| +1 | K101943 | Synthetic, Powder-Free Nitrile Examination Gloves | Tangshan Jiteng Plastic Products Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K071072 | Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination GloveSummary page 2…MEDLINE Substantial and parameters Enterprise Star Corp INDUSTRIES, Equivalence Shanghai Co., (K) 071072 INC (SE) LTD (New (K) 040841 Devi… | 2007 |
| * | K040841 | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)Summary page 2…S, Equivalence Shanghai Co., (K) 071072 INC (SE) LTD (New (K) 040841 Device) Product Code LZA LZA LZA Intended Use A powder free… | 2004 |
What descends from it? (5)
3 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K102593 (Zibo Yinghao Medical Products Co., Ltd., 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Chemotherapy drugs with their breakthrough times:
Dacarbazine 240 minutes
Cyclophosphamide(Cytoxan) 240 minutes
Doxorubicin Hydrochloride 240 minutes
Fluorouracil 240 minutes
Cisplatin 240 minutes
Etoposide (Toposar) 240 minutes
Paclitaxel (Taxol) 240 minutes
Thio-Tepa 23.3 minutes
Carmustine 18.7 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090336: Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090336
Report an extraction error
Are you the manufacturer?
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