510(k) · Cleared
ClearedNon-Sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer Coating
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 Jun 15, 2007 as substantially equivalent to K060753 (Siam Sempermed Corp., Ltd., 2006) after a 100-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Jun 15, 2007
- Review
- 100 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000323 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK000323 Nitrile Patient Examination Glove (Blue Color) Powder Free, Non…Siam Sempermed Corp., Ltd. · 2000
- 1 generation backK060753 Non-Sterile, Powder Free Nitrile Examination Glove, Blue with…Siam Sempermed Corp., Ltd. · 2006
- This deviceK070639 Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with…Siam Sempermed Corp., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK161074 Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000323 | Nitrile Patient Examination Glove (Blue Color) Powder Free, Non Sterile | Siam Sempermed Corp., Ltd. | 2000 | — |
| −1 | K060753 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating… | Siam Sempermed Corp., Ltd. | 2006 | — |
| 0 (this device) | K070639 | Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer Coating | Siam Sempermed Corp., Ltd. | 2007 | — |
| +1 | K161074 | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color | Shen Wei (Usa), Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K060753 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating, Model…Summary page 2…tabulated comparison as below. Technical comparison of specific elements is attached in the main submission. FDA file reference nume 5 10k number: K(060753 Attachments inside notification REFER ~TO APP~ENDIX 1 submission file TECHNOLOGICAL Comparison result C… | 2006 |
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 |
|---|---|---|---|
| K161074 | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color | 2016 | 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 7 years and passes through 1 company; a new generation was cleared every 6.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K161074 (Shen Wei (Usa), Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K060753.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 examiners hand
or finger to prevent contamination betweeen patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070639 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070639: Non-Sterile, Powder-Free Nitrile Examination Glove, Blue with Polymer Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070639
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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