510(k) · Cleared
ClearedPalm-Pro 0.30MM Powder Free Latex Examinaion Gloves (6PF2G30)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dipped Products Limited · LYY Latex Patient Examination Glove
Cleared on May 27, 2011 as substantially equivalent to K022808 (Wrp Specialty Products Sdn. Bhd., 2002) and 1 other predicate after a 422-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- May 27, 2011
- Review
- 422 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K935315 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK935315 Maytex Powder-Free Latex Examination GlovesMaytex Corp. · 1994
- This deviceK100895 Palm-Pro 0.30MM Powder Free Latex Examinaion Gloves (6PF2G30)Dipped Products Limited · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935315 | Maytex Powder-Free Latex Examination Gloves | Maytex Corp. | 1994 | — |
| 0 (this device) | K100895 | Palm-Pro 0.30MM Powder Free Latex Examinaion Gloves (6PF2G30) | Dipped Products Limited | 2011 | — |
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 |
|---|---|---|---|
| * | K022808 | Dermagrip Powder Free Latex Examination Gloves, Non-Sterile with Protein Content…Summary page 1…Product Description Predicate I Dermagrip Powder Free Latex WRP Examination Cloves 510(k) Number: K022808 ___________________ Predicate 2 Maytex Powder-Free Latex Exam Maytex Corporation… | 2002 |
| * | K935315 | Maytex Powder-Free Latex Examination GlovesSummary page 1…___________________ Predicate 2 Maytex Powder-Free Latex Exam Maytex Corporation Gloves 510(k) Number: K935315 ___________________ 4.0 Description of the Device: Patient Examination Gloves (21 CFR 880.6250) Product Cla… | 1994 |
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?
- None of the 2 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. 2011, 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?
Palm Pro X - Powder Free Latex Examination Gloves (6PF2G30) 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/K100895 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100895: Palm-Pro 0.30MM Powder Free Latex Examinaion Gloves (6PF2G30).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100895
Report an extraction error
Are you the manufacturer?
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