510(k) · Cleared
ClearedNon-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs Blue-AC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yty Industry (Manjung) Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on May 1, 2020 after a 67-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 1, 2020
- Review
- 67 days
- Class
- Class I
- Product code
- LZA
- 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 LZA? 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 LZA device
- #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 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 LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LZA
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZA
110in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZA
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZA
73in 2025
MAUDE reports naming product code LZA, 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 | 21 | 95 | 0 | 7 |
| 2008 | 18 | 97 | 0 | 2 |
| 2009 | 28 | 112 | 0 | 12 |
| 2010 | 31 | 97 | 0 | 12 |
| 2011 | 26 | 122 | 0 | 9 |
| 2012 | 33 | 110 | 0 | 11 |
| 2013 | 20 | 130 | 0 | 10 |
| 2014 | 27 | 197 | 0 | 8 |
| 2015 | 20 | 112 | 1 | 12 |
| 2016 | 30 | 171 | 1 | 25 |
| 2017 | 44 | 124 | 0 | 4 |
| 2018 | 22 | 178 | 0 | 3 |
| 2019 | 25 | 212 | 0 | 21 |
| 2020 | 30 | 101 | 0 | 4 |
| 2021 | 139 | 111 | 0 | 20 |
| 2022 | 146 | 111 | 0 | 19 |
| 2023 | 62 | 92 | 0 | 24 |
| 2024 | 30 | 89 | 0 | 76 |
| 2025 | 24 | 110 | 0 | 73 |
| 2026 | 15 | 103 | 3 | — |
What is it indicated for?
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: Blue Tested Chemotherapy Drug And Concentration Average Breakthrough…
Read the full statement (470 words)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
Blue
Tested Chemotherapy Drug And Concentration Average Breakthrough Detection Time (minutes)
Carboplatin, 10 mg/ml > 240 minutes
Carmustine, 3.3 mg/ml 11.3 minutes
Cisplatin (BCNU), 1.0 mg/ml > 240 minutes
Cyclophosphamide (Cytoxan), 20.0 mg/ml > 240 minutes
Dacarbazine (DTIC), 10.0 mg/ml > 240 minutes
Doxorubicin Hydrochloride, 2.0 mg/ml > 240 minutes
Etoposide (Toposar), 20.0 mg/ml > 240 minutes
Fluorouracil, 50.0 mg/ml > 240 minutes
Ifosfamide, 50.0 mg/ml > 240 minutes
Methotrexate, 25 mg/ml > 240 minutes
Mitomycin C, 0.5 mg/ml > 240 minutes
Mitoxantrone, 2 mg/ml > 240 minutes
Paclitaxel (Taxol), 6.0 mg/ml > 240 minutes
ThioTEPA, 10.0 mg/ml 7.4 minutes
Vincristine Sulfate, 1.0 mg/ml > 240 minutes
The following chemotherapy drugs and concentration have extremely low permeation time.
Carmustine (3.3 mg/ml): 11.3 minutes ThioTEPA (10.0 mg/ml): 7.4 minutes
WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl Citrate:
Blue
Tested Chemotherapy Drug And Concentration Average Breakthrough Detection Time (minutes)
Carboplatin, 10 mg/ml > 240 minutes
Carmustine, 3.3 mg/ml 30.3 minutes
Cisplatin (BCNU), 1.0 mg/ml > 240 minutes
Cyclophosphamide (Cytoxan), 20.0 mg/ml > 240 minutes
Dacarbazine (DTIC), 10.0 mg/ml > 240 minutes
Doxorubicin Hydrochloride, 2.0 mg/ml > 240 minutes
Etoposide (Toposar), 20.0 mg/ml > 240 minutes
Fluorouracil, 50.0 mg/ml > 240 minutes
Ifosfamide, 50.0 mg/ml > 240 minutes
Methotrexate, 25 mg/ml > 240 minutes
Mitomycin C, 0.5 mg/ml > 240 minutes
Mitoxantrone, 2 mg/ml > 240 minutes
Paclitaxel (Taxol), 6.0 mg/ml > 240 minutes
ThioTEPA, 10.0 mg/ml 91.0 minutes
Vincristine Sulfate, 1.0 mg/ml > 240 minutes
Busulfan, 6 mg/ml > 240 minutes
Cytarabine, 100 mg/ml > 240 minutes
Daunorubicin, 5 mg/ml > 240 minutes
Docetaxel, 10 mg/ml > 240 minutes
Epirubicin, 2 mg/ml > 240 minutes
Gemcitabine, 38 mg/ml > 240 minutes
Irinotecan Hydrochloride, 20 mg/ml > 240 minutes
Mechlorethamine HCL, 1.0 mg/ml > 240 minutes
Melphalan, 5 mg/ml > 240 minutes
Trisenox, 0.1 mg/ml > 240 minutes
Fentanyl Citrate, 100mcg/2ml > 240 minutes
The following chemotherapy drugs and concentration have extremely low permeation time.
Carmustine (3.3 mg/ml): 30.3 minutes ThioTEPA (10.0 mg/ml): 91.0 minutes
CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHERAPY DRUGS
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K200453 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200453: Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs Blue-AC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200453
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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