510(k) · Cleared
ClearedNon-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color, Polymer Coated, Texted with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siam Sempermed Corp., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Mar 5, 2009 as substantially equivalent to K080520 (Siam Sempermed Corp., Ltd., 2008) after a 78-day review. Its family tree reaches back 3 generations to 2000. 16 later devices descend from it.
- Decided
- Mar 5, 2009
- Review
- 78 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000323 (2000). 16 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK000323 Nitrile Patient Examination Glove (Blue Color) Powder Free, Non…Siam Sempermed Corp., Ltd. · 2000
- 2 generations backK060753 Non-Sterile, Powder Free Nitrile Examination Glove, Blue with…Siam Sempermed Corp., Ltd. · 2006
- 1 generation backK080520 Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer…Siam Sempermed Corp., Ltd. · 2008
- This deviceK083755 Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue…Siam Sempermed Corp., Ltd. · 2009
- Descendant · cites it directly · 8 of its ownK182241 Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for…Sri Trang Gloves (Thailand) Co., Ltd. · 2019
- Descendant · 2 generations on · 3 of its ownK200072 KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use…Kimberly-Clark Corporation · 2020
- Descendant · 2 generations on · 3 of its ownK193581 Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with…Sri Trang Gloves (Thailand) Public Company Limited · 2020
- Descendant · cites it directly · 3 of its ownK171378 Non-Sterile, Single use, Powder-free examination glove tested for…Semperit Investments Asia Pte, Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK223903 Non-Sterile, Single use, Powder-free examination glove, Blue, tested…Semperit Investments Asia Pte, Ltd. · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K182241Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with…Sri Trang Gloves (Thailand) Co., Ltd. · 2019 · cites it directly8descendants
- K200072KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy…Kimberly-Clark Corporation · 2020 · 2 generations on3descendants
- K193581Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs -…Sri Trang Gloves (Thailand) Public Company Limited · 2020 · 2 generations on3descendants
- K171378Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy…Semperit Investments Asia Pte, Ltd. · 2017 · cites it directly3descendants
- K223903Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with…Semperit Investments Asia Pte, Ltd. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000323 | Nitrile Patient Examination Glove (Blue Color) Powder Free, Non Sterile | Siam Sempermed Corp., Ltd. | 2000 | — |
| −2 | K060753 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating… | Siam Sempermed Corp., Ltd. | 2006 | — |
| −1 | K080520 | Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with… | Siam Sempermed Corp., Ltd. | 2008 | — |
| 0 (this device) | K083755 | Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color… | Siam Sempermed Corp., Ltd. | 2009 | — |
| +1 | K182241 | Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with… | Sri Trang Gloves (Thailand) Co., Ltd. | 2019 | — |
| +2 | K200072 | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with… | Kimberly-Clark Corporation | 2020 | — |
| +2 | K193581 | Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy… | Sri Trang Gloves (Thailand) Public Company Limited | 2020 | — |
| +1 | K171378 | Non-Sterile, Single use, Powder-free examination glove tested for use with… | Semperit Investments Asia Pte, Ltd. | 2017 | — |
| +2 | K223903 | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use… | Semperit Investments Asia Pte, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K080520 | Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with…Summary page 2…n the tabulated comparison as below. Technical comparison of specific elements is attached in the main submission. FDA file reference number 5 10k number: K080520 Attachments inside notification REFER TO APPENDIX 1 submission file TECHNOLOGICAL Comparison resul… | 2008 |
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182241 | Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with… | 2019 | 8 |
| K171378 | Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy… | 2017 | 3 |
| K121549 | Non-Sterile, Powder-Free Nitrile Examination Glove, Blue | 2012 | 1 |
| K122363 | Non-Sterile, Powder Free Nitrile Examination Gloves, Blue | 2012 | 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 9 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K182241 (Sri Trang Gloves (Thailand) Co., Ltd., 2019) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K080520.
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 patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs are as follows: Amethopterin Hydrate (Methotrexate), Cisplatin, Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), 5-Fluorouracil, Paclitaxel (Taxol), and Vincristine Sulfate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083755: Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color, Polymer Coated, Texted 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/K083755
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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