510(k) · Cleared
ClearedSatari Powdered Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Polymer Coated Whit
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 Feb 28, 2002 as substantially equivalent to K981096 (Semperit Technische Produkte Gesellshaft, 1998) after a 76-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Feb 28, 2002
- Review
- 76 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981096 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981096 Sempermed Surgeons' Gloves - SupremeSemperit Technische Produkte Gesellshaft · 1998
- This deviceK014110 Satari Powdered Latex Examination Gloves with Protein Content…Siam Sempermed Corp., Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981096 | Sempermed Surgeons' Gloves - Supreme | Semperit Technische Produkte Gesellshaft | 1998 | — |
| 0 (this device) | K014110 | Satari Powdered Latex Examination Gloves with Protein Content Labeling Claim… | Siam Sempermed Corp., Ltd. | 2002 | — |
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? (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 |
|---|---|---|---|
| * | K981096 | Sempermed Surgeons' Gloves - SupremeSummary page 1…Patient Examination, Latex 15-Substantial Equivalency is claimed against the following device: Siam Sempermed Latex Patient Examination Glove Polymer powder [ree, 510k #k981096 (refer to Appendix 2 for FDA website printout. This notification for the SATARI® latex examination glove is of the ABBREVIATED t… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K981096.
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?
This device is a disposable device intended for medical purposes that is worn on the examiner’s hand 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/K014110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014110: Satari Powdered Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Polymer Coated Whit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014110
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026