510(k) · Cleared
ClearedLatex Examination Glove Powder Free (Ocean Blue and Natural White)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sri Trang Gloves (Thailand) Public Company Limited · LYY Latex Patient Examination Glove
Cleared on Sep 9, 2024 after a 222-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 9, 2024
- Review
- 222 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. 2024, 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 device 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 permeation times are as follows: Bleomycin Sulfate 15 mg/mL, >240 minutes lfosfamide 50 mg/mL, >240 minutes Busulfan 6 mg/mL, >240 minutes Irinotecan 20 mg/mL, >240 minutes Carboplatin (Paraplatin) 10 mg/mL, >240 minutes Mechlorethamine HCl 1 mg/mL, >240 minutes…
Read the full statement (214 words)
This device 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 permeation times are as follows:
Bleomycin Sulfate 15 mg/mL, >240 minutes lfosfamide 50 mg/mL, >240 minutes
Busulfan 6 mg/mL, >240 minutes Irinotecan 20 mg/mL, >240 minutes
Carboplatin (Paraplatin) 10 mg/mL, >240 minutes Mechlorethamine HCl 1 mg/mL, >240 minutes
Carmustine (BCNU) 3.3 mg/mL, 1.9 minutes Melphalan 5 mg/mL, >240 minutes
Cisplatin 1.0 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes
Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Mitomycin C 0.5 mg/mL, >240 minutes
Cytarabine HCl 100 mg/mL, >240 minutes Mitoxantrone 2 mg/mL, >240 minutes
Dacarbazine (DTIC) 10 mg/mL, >240 minutes Paclitaxel (Taxol) 6 mg/mL, >240 minutes
Daunorubicin HCl 5 mg/mL, >240 minutes Rituximab 10 mg/mL, >240 minutes
Docetaxel 20 mg/mL, >240 minutes Thiotepa 10 mg/mL, 3.7 minutes
Doxorubicin Hydrochloride 2 mg/mL, >240 minutes Trisenox 1 mg/mL , >240 minutes
Epirubicin HCl (Ellence) 2 mg/mL, >240 minutes Vincristine Sulfate 1 mg/mL, >240 minutes
Etoposide (Toposar) 20 mg/mL, >240 minutes
Fludarabine 25 mg/mL, >240 minutes Fentanyl tested as follows:
Fluorouracil 50 mg/mL, >240 minutes Fentanyl citrate 100 mcg/2mL, >240 minutes
Gemcitabine 38 mg/mL, >240 minutes
Idarubicin HCl 1 mg/mL, >240 minutes
WARNING: Not for use with Carmustine or Thiotepa.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K240266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240266: Latex Examination Glove Powder Free (Ocean Blue and Natural White).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240266
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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