510(k) · Cleared
ClearedTextured, Blue, Latex, Powder Free Examination Glvoes, with Protein Labeling Claim (50UG/DM or Less of Water Soluble Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Northstar Healthcare Holdings · LYY Latex Patient Examination Glove
Cleared on Nov 16, 2012 as substantially equivalent to K062917 (Wear Safe Malaysia Sdn. Bhd., 2006) after a 49-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Nov 16, 2012
- Review
- 49 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062917 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK062917 Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove…Wear Safe Malaysia Sdn. Bhd. · 2006
- This deviceK123026 Textured, Blue, Latex, Powder Free Examination Glvoes, with Protein…Northstar Healthcare Holdings · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062917 | Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove, with… | Wear Safe Malaysia Sdn. Bhd. | 2006 | — |
| 0 (this device) | K123026 | Textured, Blue, Latex, Powder Free Examination Glvoes, with Protein Labeling… | Northstar Healthcare Holdings | 2012 | — |
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 |
|---|---|---|---|
| * | K062917 | Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove, with Extractable…Summary page 1…Indication Clearance Company 510(k) Date K0629 17 Latex Powder Free The latex examination glove is a 02 Nov 2006 Wear Safe SON, Examinat… | 2006 |
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.
- 1 other device also cites its predicate K062917.
How does its category compare?
All LYY devicesLYY Latex 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 · 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?
The examination glove is a disposable device intended for medical purposes that is worn on the examinees hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123026: Textured, Blue, Latex, Powder Free Examination Glvoes, with Protein Labeling Claim (50UG/DM or Less of Water Soluble Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123026
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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