510(k) · Cleared
ClearedNon-Sterile Powder Free Natural/Green Lano-E Latex Exam Gloves, with or Wihout Citrus/Peppermint Scent Plus a Protein
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascend Eagle, Inc. · LYY Latex Patient Examination Glove
Cleared on Jan 25, 2006 as substantially equivalent to K032293 (Sgmp Co., Ltd., 2003) and 1 other predicate after a 120-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jan 25, 2006
- Review
- 120 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011370 (2001). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK011370 Non-Sterile Powder Free Purple Latex Examination Glove with and…Sgmp Co., Ltd. · 2001
- 1 generation backK032293 Non-Sterile, Powder Free Green Latex Examination Gloves with or…Sgmp Co., Ltd. · 2003
- This deviceK052666 Non-Sterile Powder Free Natural/Green Lano-E Latex Exam Gloves, with…Ascend Eagle, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011370 | Non-Sterile Powder Free Purple Latex Examination Glove with and Without Grape… | Sgmp Co., Ltd. | 2001 | — |
| −1 | K032293 | Non-Sterile, Powder Free Green Latex Examination Gloves with or Without Sour… | Sgmp Co., Ltd. | 2003 | — |
| 0 (this device) | K052666 | Non-Sterile Powder Free Natural/Green Lano-E Latex Exam Gloves, with or Wihout… | Ascend Eagle, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (2)
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 |
|---|---|---|---|
| * | K032293 | Non-Sterile, Powder Free Green Latex Examination Gloves with or Without Sour Apple or…Summary page 1…this device is equivalent to devices currently marketed by US companies. It is Substantially Equivalent to the devices manufactured by SGMP Co., LTD, except by coating, K032293, and by N.S. Uni-Gloves Sdn. Bhd., except by scent, K013163. Summary of Technological Characteristics: Material: Latex Cuff:… | 2003 |
| * | K013163 | Uniglove Lano-E Powder-Free Latex Examination GlovesSummary page 1…US companies. It is Substantially Equivalent to the devices manufactured by SGMP Co., LTD, except by coating, K032293, and by N.S. Uni-Gloves Sdn. Bhd., except by scent, K013163. Summary of Technological Characteristics: Material: Latex Cuff: Beaded Powder Residue: Maximum 2mg/glove Quality Assur… | 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 5 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
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?
The Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Color, With or Without Scent (Combined Citrus-Peppermint), and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052666: Non-Sterile Powder Free Natural/Green Lano-E Latex Exam Gloves, with or Wihout Citrus/Peppermint Scent Plus a Protein.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052666
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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