510(k) · Cleared
ClearedLatex Examination Powder Free Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aspen Glove Sdn. Bhd. · LYY Latex Patient Examination Glove
Cleared on Sep 20, 2021 as substantially equivalent to K192329 (Jr Engineering & Medical Technologies (M) Sdn. Bhd., 2019) after a 131-day review. Its family tree reaches back 2 generations to 2015.
- Decided
- Sep 20, 2021
- Review
- 131 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K141042 (2015). No later device cites it as a predicate yet.
- Root · 2 generations backK141042 Mcare PF Powder Free Latex Examination High Risk GlovesMercator Medical (Thailand), Ltd. · 2015
- 1 generation backK192329 Blue Latex Examination Powder Free GlovesJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2019
- This deviceK211477 Latex Examination Powder Free GlovesAspen Glove Sdn. Bhd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K141042 | Mcare PF Powder Free Latex Examination High Risk Gloves | Mercator Medical (Thailand), Ltd. | 2015 | — |
| −1 | K192329 | Blue Latex Examination Powder Free Gloves | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2019 | — |
| 0 (this device) | K211477 | Latex Examination Powder Free Gloves | Aspen Glove Sdn. Bhd. | 2021 | — |
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 12.8 · 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 |
|---|---|---|---|
| * | K192329 | Blue Latex Examination Powder Free GlovesSummary page 4…al Hospital C. PREDICATE DEVICE Legally Marketed devices JR Medic Powder free Latex Examination Gloves that Equivalency is claimed 510(K) Number K192329 Regulatory Class Class I Product code LYY D. DESCRIPTION OF THE DEVICE: Latex Examination Powde… | 2019 |
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 6 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 2 ancestors has a recall.
- 5 other devices also cite its predicate K192329.
How does its category compare?
All LYY devicesLYY Latex Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Latex Examination Powder Free Gloves are disposable device intended for medical purpose 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/K211477 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211477: Latex Examination Powder Free Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211477
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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