510(k) · Cleared
ClearedLatex Patient Examination (Powderfree Glove)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siam Sempermed Corp., Ltd. · LYY Latex Patient Examination Glove
Cleared on May 6, 1997 after a 63-day review. The FDA summary names no predicate by number. 8 later devices descend from it.
- Decided
- May 6, 1997
- Review
- 63 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 5 citing it directly.
- This deviceK970794 Latex Patient Examination (Powderfree Glove)Siam Sempermed Corp., Ltd. · 1997
- Descendant · cites it directly · 2 of its ownK024121 Non-Sterile, Powder-Free Latex Examination Gloves with Polymer…Siam Sempermed Corp., Ltd. · 2002
- Descendant · 2 generations on · 1 of its ownK121549 Non-Sterile, Powder-Free Nitrile Examination Glove, BlueSiam Sempermed Corp., Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK100907 Non-Sterile, Powder Free Latex Examination Gloves and Protein Claim…Siam Sempermed Corp., Ltd. · 2010
- Descendant · 3 generations on · 0 of its ownK142685 Nitrile Examination Gloves with Aloe & Vitamin E, Powder- FreeSiam Sempermed Corp., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK111133 Non-Sterile, Powder Free Latex Examination Gloves with Protein Claim…Ssc Surat Thani · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K024121Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating, Aloe, Vitamin E…Siam Sempermed Corp., Ltd. · 2002 · cites it directly2descendants
- K121549Non-Sterile, Powder-Free Nitrile Examination Glove, BlueSiam Sempermed Corp., Ltd. · 2012 · 2 generations on1descendant
- K100907Non-Sterile, Powder Free Latex Examination Gloves and Protein Claim (50 Micrograms or…Siam Sempermed Corp., Ltd. · 2010 · cites it directly1descendant
- K142685Nitrile Examination Gloves with Aloe & Vitamin E, Powder- FreeSiam Sempermed Corp., Ltd. · 2015 · 3 generations on0descendants
- K111133Non-Sterile, Powder Free Latex Examination Gloves with Protein Claim (50 MG or Less)Ssc Surat Thani · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970794 | Latex Patient Examination (Powderfree Glove) | Siam Sempermed Corp., Ltd. | 1997 | — |
| +1 | K024121 | Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating, Aloe… | Siam Sempermed Corp., Ltd. | 2002 | — |
| +2 | K121549 | Non-Sterile, Powder-Free Nitrile Examination Glove, Blue | Siam Sempermed Corp., Ltd. | 2012 | — |
| +1 | K100907 | Non-Sterile, Powder Free Latex Examination Gloves and Protein Claim (50… | Siam Sempermed Corp., Ltd. | 2010 | — |
| +3 | K142685 | Nitrile Examination Gloves with Aloe & Vitamin E, Powder- Free | Siam Sempermed Corp., Ltd. | 2015 | — |
| +2 | K111133 | Non-Sterile, Powder Free Latex Examination Gloves with Protein Claim (50 MG or… | Ssc Surat Thani | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 LYY? 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 LYY device
- #1 K202377 Palm Care Latex Examination Powder Free Glovesscore 12.7 · 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?
The FDA summary names no predicate by number.
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024121 | Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating, Aloe, Vitamin E… | 2002 | 2 |
| K100907 | Non-Sterile, Powder Free Latex Examination Gloves and Protein Claim (50 Micrograms or… | 2010 | 1 |
| K081907 | Non-Sterile, Powder Free Latex Examination Gloves with Polymer Coating and Protein Claim… | 2008 | 0 |
| K051329 | Sterile Powder-Free Latex Examination Gloves with Polymer Coating and Protein Claim (50… | 2005 | 0 |
| K024106 | Non-Sterile, Powder-Free Latex Examination Gloves with Polymer Coating, Vitamin E and… | 2002 | 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?
- Of its descendants, K024121 (Siam Sempermed Corp., Ltd., 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LYY devicesLYY Latex Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYY
150in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYY
1in 2025
MAUDE reports naming product code LYY, 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 | 12 | 75 | 0 | 11 |
| 2008 | 13 | 151 | 0 | 14 |
| 2009 | 7 | 76 | 0 | 11 |
| 2010 | 13 | 106 | 0 | 10 |
| 2011 | 11 | 127 | 1 | 4 |
| 2012 | 11 | 133 | 0 | 1 |
| 2013 | 6 | 131 | 0 | 2 |
| 2014 | 3 | 156 | 0 | 6 |
| 2015 | 3 | 251 | 0 | 5 |
| 2016 | 4 | 142 | 0 | 7 |
| 2017 | 4 | 230 | 0 | 7 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 7 |
| 2020 | 1 | — | 1 | 1 |
| 2021 | 8 | 188 | 0 | 1 |
| 2022 | 14 | 150 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
A patient examination glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970794: Latex Patient Examination (Powderfree Glove).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970794
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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