510(k) · Cleared
ClearedEudermic MP Latex Examination Glove-Blue (Tested for Use with Chemotherapy Drugs) W/ a Protein Content Label Claim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · LYY Latex Patient Examination Glove
Cleared on Apr 21, 2011 after a 134-day review. The FDA summary names no predicate by number.
- Decided
- Apr 21, 2011
- Review
- 134 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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.
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?
The Eudermic MP Powder-Free Latex Examination Glove (tested for use with chemotherapy drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The tested chemotherapy drugs and their breakthrough detection times are as follows: Chemotherapy Drug — Average BDT 5-Fluorouracil — >240 min. Etoposide (Toposar) — >240 min. Cyclophosphamide (Cytoxan) — >240 min.…
Read the full statement (128 words)
The Eudermic MP Powder-Free Latex Examination Glove (tested for use with chemotherapy drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
Chemotherapy Drug — Average BDT
5-Fluorouracil — >240 min.
Etoposide (Toposar) — >240 min.
Cyclophosphamide (Cytoxan) — >240 min.
Carmustine — 6.26 min.
Thiotepa — 12.13 min.
Paclitaxel (Taxol) — >240 min.
Doxorubicin Hydrochloride — >240 min.
Dacarbazine (DTIC) — >240 min.
Cisplatin — >240 min.
Ifosfamide (Ifex) — >240 min.
Mitoxantrone — >240 min.
Vincristine Sulfate — >240 min.
Please note that the following drugs have extremely low permeation times:
* Carmustine — 6.26 minutes
* Thiotepa — 12.13 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103602: Eudermic MP Latex Examination Glove-Blue (Tested for Use with Chemotherapy Drugs) W/ a Protein Content Label Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103602
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026