510(k) · Cleared
ClearedPowder Free Latex Examination Gloves (18 ML), Blue Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gx Corporation Sdn Bhd · LYY Latex Patient Examination Glove
Cleared on Oct 4, 2010 after a 95-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 4, 2010
- Review
- 95 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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. 2010, 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?
This glove is a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner. Chemotherapy Drug Permeation (Average Breakthrough Detection Time in Minutes) Thiotepa (10.0 mg / ml) 7.71 Carmustine (BCNU) (3.3 mg I ml) 63.03 Dacarbazine (DTIC) (10.0 mg I ml) > 240 Cyclophosphamide (Cytoxan) (20.0 mg Iml) > 240. Doxorubicin Hydrochloride (2.0 mg Iml) > 240 Fluorouracil (50.0 mg I…
Read the full statement (144 words)
This glove is a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Chemotherapy Drug Permeation (Average Breakthrough Detection Time in Minutes)
Thiotepa (10.0 mg / ml) 7.71
Carmustine (BCNU) (3.3 mg I ml) 63.03
Dacarbazine (DTIC) (10.0 mg I ml) > 240
Cyclophosphamide (Cytoxan) (20.0 mg Iml) > 240.
Doxorubicin Hydrochloride (2.0 mg Iml) > 240
Fluorouracil (50.0 mg I mI4 > 240
Cisplatin (1.0 mg I ml) > 240
Etoposide (Toposar) (20.0 mg I ml) > 240
Paclitaxel (Taxol) (6.0 mg Iml) > 240
Ifosfamide. (50.0 mg I ml). > 240
Methotrexate (25.0 mg I ml) > 240
Mitomycin 0 (0.5 mg Iml) >240
Mitoxantrone (2.0 mg Iml) > 240
Vincristine Sulfate (1.0mng / ml) >'240
Please note that Thiotepa has an extremely low permeation time of less than 30 minutes
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K101828 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101828: Powder Free Latex Examination Gloves (18 ML), Blue Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101828
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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