510(k) · Cleared
ClearedNon-Sterile, Powder-Free Nitrile Examination Glove, Blue
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 Dec 27, 2012 as substantially equivalent to K083755 (Siam Sempermed Corp., Ltd., 2009) and 1 other predicate after a 216-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Dec 27, 2012
- Review
- 216 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000323 (2000). 6 ancestors in all, the oldest K970794 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK000323 Nitrile Patient Examination Glove (Blue Color) Powder Free, Non…Siam Sempermed Corp., Ltd. · 2000
- 3 generations backK060753 Non-Sterile, Powder Free Nitrile Examination Glove, Blue with…Siam Sempermed Corp., Ltd. · 2006
- 2 generations backK080520 Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer…Siam Sempermed Corp., Ltd. · 2008
- 1 generation backK083755 Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue…Siam Sempermed Corp., Ltd. · 2009
- This deviceK121549 Non-Sterile, Powder-Free Nitrile Examination Glove, BlueSiam Sempermed Corp., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK142685 Nitrile Examination Gloves with Aloe & Vitamin E, Powder- FreeSiam Sempermed Corp., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142685Nitrile Examination Gloves with Aloe & Vitamin E, Powder- FreeSiam Sempermed Corp., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000323 | Nitrile Patient Examination Glove (Blue Color) Powder Free, Non Sterile | Siam Sempermed Corp., Ltd. | 2000 | — |
| −3 | K060753 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating… | Siam Sempermed Corp., Ltd. | 2006 | — |
| −2 | K080520 | Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with… | Siam Sempermed Corp., Ltd. | 2008 | — |
| −1 | K083755 | Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color… | Siam Sempermed Corp., Ltd. | 2009 | — |
| 0 (this device) | K121549 | Non-Sterile, Powder-Free Nitrile Examination Glove, Blue | Siam Sempermed Corp., Ltd. | 2012 | — |
| +1 | K142685 | Nitrile Examination Gloves with Aloe & Vitamin E, Powder- Free | Siam Sempermed Corp., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K083755 | Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color, Polymer Coated…Summary page 2…Table 1. Table 1. Side-by-side Comparison of Predicate Devices with Subject Device Device Description Predicate 1: K083755 Predicate 2: K(024121 Subiect device Substantial Non-Sterile, Powder Free… | 2009 |
| * | K024121 | Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating, Aloe, Vitamin E…Summary page 2…nitrile synthetic latex material using the same production process. The subject device lacks the chemotherapy claim of predicate K083755. Although predicate K024121 is composed of natural rubber latex, it is treated with the same Aloe and Vitamin E coating mixture as the subject device.… | 2002 |
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 |
|---|---|---|---|
| K142685 | Nitrile Examination Gloves with Aloe & Vitamin E, Powder- Free | 2015 | 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 12 years and passes through 1 company; a new generation was cleared every 3.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K142685 (Siam Sempermed Corp., Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K083755.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
This is a medical device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121549: Non-Sterile, Powder-Free Nitrile Examination Glove, Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121549
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