510(k) · Cleared
ClearedNon Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with Chemotherapy Claim
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 Apr 30, 2008 as substantially equivalent to K060753 (Siam Sempermed Corp., Ltd., 2006) after a 65-day review. Its family tree reaches back 2 generations to 2000. 97 later devices descend from it.
- Decided
- Apr 30, 2008
- Review
- 65 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000323 (2000). 97 later devices descend from it, 3 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 deviceK080520 Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer…Siam Sempermed Corp., Ltd. · 2008
- Descendant · cites it directly · 78 of its ownK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- Descendant · 2 generations on · 77 of its ownK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- Descendant · 3 generations on · 75 of its ownK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 69 of its ownK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- Descendant · 4 generations on · 53 of its ownK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
Showing 5 of 97 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 97 · See all- K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009 · cites it directly78descendants
- K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009 · 2 generations on77descendants
- K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · 3 generations on75descendants
- K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc. · 2011 · 3 generations on69descendants
- K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012 · 4 generations on53descendants
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) | K080520 | Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with… | Siam Sempermed Corp., Ltd. | 2008 | — |
| +1 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| +2 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| +3 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
| +3 | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
| +4 | K121425 | Ortholoc 3DI Ankle Fusion Plating System | Wrightmedicaltechnologyinc | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 10 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 10 | 0 |
| 2021 | 9 | 0 |
| 2022 | 3 | 0 |
| 2023 | 14 | 0 |
| 2024 | 8 | 0 |
| 2025 | 4 | 0 |
| 2026 | 8 | 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…the tabulated comparison as below. Technical comparison of specific elements is attached in the main submission. FDA file reference number 5 10k number: k060753 Attachments inside notification REFER TO APPENDIX 1 TECHNOLOGICAL ~~Comparison result TCHNRACERI… | 2006 |
What descends from it? (97)
See all 973 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 8 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, K090420 (Smith & Nephew, Inc., 2009) has gone furthest, with 78 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. 2008, 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 betweeen patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080520: Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with Chemotherapy Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080520
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