510(k) · Cleared
ClearedPowderfree Latex Examination Gloves Coated with Allogel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Preventive Care, Inc. · LYY Latex Patient Examination Glove
Cleared on Jul 24, 2013 as substantially equivalent to K110102 (Preventive Care, Inc., 2011) after a 134-day review. Its family tree reaches back 1 generation to 2011.
- Decided
- Jul 24, 2013
- Review
- 134 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K110102 (2011). No later device cites it as a predicate yet.
- Root · 1 generation backK110102 Powderfree Nitrile Examination Gloves Coated with Allogel,Colors…Preventive Care, Inc. · 2011
- This deviceK130667 Powderfree Latex Examination Gloves Coated with AllogelPreventive Care, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K110102 | Powderfree Nitrile Examination Gloves Coated with Allogel,Colors… | Preventive Care, Inc. | 2011 | — |
| 0 (this device) | K130667 | Powderfree Latex Examination Gloves Coated with Allogel | Preventive Care, Inc. | 2013 | — |
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 |
|---|---|---|---|
| * | K110102 | Powderfree Nitrile Examination Gloves Coated with Allogel,Colors Blue,Magneta,Copper and…Summary page 1…atient Examination Glove Classification Number: Class 1 Regulation Number: 21 CFR 880.6250 Product code: LYY 4. Legally Marketed Device to which equivalency is claimed: K110102 Powderfree Nitrile Examination Gloves Coated with AllogelO, LZA, Class 1, that meets or exceeds all the applicable requirements o… | 2011 |
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.
How does its category compare?
All LYY devicesLYY Latex Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
An Examination glove Is a disposable device Intended for medical purposes that Is worn on the examiners hand or finger, to prevent contamination between the patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130667: Powderfree Latex Examination Gloves Coated with Allogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130667
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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