510(k) · Cleared
ClearedEvergreen Non-Sterile Powdered Natural or Colored Latex Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yty Industry (Manjung) Sdn Bhd · LYY Latex Patient Examination Glove
Cleared on Feb 3, 2003 as substantially equivalent to K943807 (Shield Gloves Manufacturer (M) Sdn Bhd, 1994) and 2 other predicates after a 35-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Feb 3, 2003
- Review
- 35 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K943807 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK943807 Royal Shield Pink Colored Non-Sterile Latex Examination GloveShield Gloves Manufacturer (M) Sdn Bhd · 1994
- 1 generation backK023590 Powdered Natural and/or Colored Latex Exam GlovesYty Industry (Manjung) Sdn Bhd · 2002
- This deviceK024355 Evergreen Non-Sterile Powdered Natural or Colored Latex Examination…Yty Industry (Manjung) Sdn Bhd · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943807 | Royal Shield Pink Colored Non-Sterile Latex Examination Glove | Shield Gloves Manufacturer (M) Sdn Bhd | 1994 | — |
| −1 | K023590 | Powdered Natural and/or Colored Latex Exam Gloves | Yty Industry (Manjung) Sdn Bhd | 2002 | — |
| 0 (this device) | K024355 | Evergreen Non-Sterile Powdered Natural or Colored Latex Examination Glove | Yty Industry (Manjung) Sdn Bhd | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (3)
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 |
|---|---|---|---|
| * | K943807 | Royal Shield Pink Colored Non-Sterile Latex Examination GloveSummary page 3…Primary Skin Irritation Conclusion: This device is substantially equivalent to the devices approved as K943807, K974191 and K023590. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Ser… | 1994 |
| * | K974191 | Evergreen Non-Sterile Powdered Latex Examination GloveSummary page 3…Primary Skin Irritation Conclusion: This device is substantially equivalent to the devices approved as K943807, K974191 and K023590. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 1997 |
| * | K023590 | Powdered Natural and/or Colored Latex Exam GlovesSummary page 3…Primary Skin Irritation Conclusion: This device is substantially equivalent to the devices approved as K943807, K974191 and K023590. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2002 |
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K943807.
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 is a medical glove to be worn on the hand of health care and similar personnel to prevent
contamination between health care personnel and the patient.
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/K024355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024355: Evergreen Non-Sterile Powdered Natural or Colored Latex Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024355
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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