510(k) · Cleared
ClearedBlue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Central Medicare Sdn Bhd · LZC Medical Glove, Specialty
Cleared on Jul 4, 2019 after a 233-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 4, 2019
- Review
- 233 days
- Class
- Class I
- Product code
- LZC
- 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 LZC? 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 LZC device
- #1 K201390 Medline Powder-Free Light Blue Nitrile Exam…score 19.2 · 5 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 LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LZC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZC
85in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZC
10in 2025
MAUDE reports naming product code LZC, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 166 | 1 | 0 |
| 2009 | 5 | 253 | 0 | 1 |
| 2010 | 5 | 68 | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 4 | 149 | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 258 | 0 | 5 |
| 2017 | 6 | 121 | 0 | 7 |
| 2018 | 6 | 105 | 0 | 6 |
| 2019 | 7 | 200 | 0 | 8 |
| 2020 | 3 | 167 | 0 | 1 |
| 2021 | 3 | 94 | 1 | 2 |
| 2022 | 7 | 85 | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Low Dermatitis Potential - this product demonstrated reduced potential for sensitizing users to chemical additives. Tested for Use with Chemotherapy Drugs -…
Read the full statement (276 words)
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Low Dermatitis and Fentanyl Permeation Resistance Claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Low Dermatitis Potential - this product demonstrated reduced potential for sensitizing users to chemical additives.
Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves:
Tested Chemotherapy Drug Concentrate(mg/ml) Minimum Breakthrough Detection Time (minutes)
Bleomycin Sulfate 15 >240
Busulfan 6 >240
Carboplatin 10 >240
*Carmustine 3.3 12.4
Cisplatin 1 >240
Chloroquine 50 >240
Cyclophosphamide 20 >240
Cyclosporin 100 >240
Cytarabine HCI 100 >240
Dacarbazine 10 >240
Daunorubicin HCI 5 >240
Docetaxel 10 >240
Doxorubicin Hydrochloride 2 >240
Epirubicin (Ellence) 2 >240
Etoposide 20 >240
Fludarabine 25 >240
Fluorouracil 50 >240
Gemcitabine 38 >240
Idarubicin 1 >240
Ifosfamide 50 >240
Irinotecan 20 >240
Mechlorethamine HCI 1 >240
Melphalan 5 >240
Methotrexate 25 >240
Mitomycin 0.5 >240
Mitoxantrone 2 >240
Oxaliplatin 5 >240
Paclitaxel 6 >240
Paraplatin 10 >240
Retrovir 10 >240
Rituximab 10 >240
*Thiotepa 10 24.4
Topotecane 1 >240
Trisonex 1 >240
Velcade 1 >240
Vincristine Sulfate 1 >240
* Please note that the following drugs have extremely low permeation times:
Carmustine: 12.4 minutes and Thiotepa: 24.4 minutes
Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K183149 · printed Nov 3, 2026
Cite this page
510(k) Report. “K183149: Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K183149
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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