510(k) · Cleared
ClearedNitrile Powder Free Examination Gloves (Vio) Tested for Use with Chenitrile Powder Free Examination (Ablu) Tested for U
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hartalega Sdn Bhd · LZC Medical Glove, Specialty
Cleared on Jun 25, 2012 after a 143-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 25, 2012
- Review
- 143 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. 2012, 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?
The Nitrile Powder Free Examination Gloves (White) Tested for Use with Chemotherapy Drugs is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested -to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) as per below: 1. Carmustine (3.3 mg/ml) — 30.2 2. Cisplatin (1.0 mg/ml) — >…
Read the full statement (692 words)
The Nitrile Powder Free Examination Gloves (White) Tested for Use with Chemotherapy Drugs is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested -to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) as per below:
1. Carmustine (3.3 mg/ml) — 30.2
2. Cisplatin (1.0 mg/ml) — > 240
3. Cyclophosphamide (Cytoxan) (20.0 mg/ml) — > 240
4. Dacarbazine (10.0 mg/ml) — > 240
5. Doxorubixin Hydrochloride (2.0 mg/ml) — > 240
6. Etoposide (Toposar) (20.0 mg/ml) — > 240
7. Fluorouracil (50.0 mg/ml) — > 240
8. Methotrexate (25.0 mg/ml) — > 240
9. Mitomycin C (0.5 mg/ml) — > 240
10. Paclitaxel (6.0 mg/ml) — > 240
11. Thiotepa (10.0 mg/ml) — > 240
12. Vincristine Sulfate (1.0 mg/ml) — > 240
Please note that the following drugs have extremely low permeation times of 30.2 minutes with Carmustine (3.3 mg/ml)
The Nitrile Powder Free Examination Gloves (VBLU - Violet Blue) Tested for Use with Chemotherapy Drugs is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) as per below:
1. Carmustine (3.3 mg/ml) — 30.3
2. Cisplatin (1.0 mg/ml) — > 240
3. Cyclophosphamide (Cytoxan) (20.0 mg/ml) — > 240
4. Dacarbazine (10.0 mg/ml) — > 240
5. Doxorubixin Hydrochloride (2.0 mg/ml) — > 240
6. Etoposide (Toposar) (20.0 mg/ml) — > 240
7. Fluorouracil (50.0 mg/ml) — > 240
8. Methotrexate (25.0 mg/ml) — > 240
9. Mitomycin C (0.5 mg/ml) — > 240
10. Paclitaxel (6.0 mg/ml) — > 240
11. Thiotepa (10.0 mg/ml) — > 240
12. Vincristine Sulfate (1.0 mg/ml) — > 240
Please note that the following drugs have extremely low permeation times of 30.3 minutes with Carmustine (3.3 mg/ml)
The Nitrile Powder Free Examination Gloves (ABLU - Aqua Blue) Tested for Use with Chemotherapy Drugs is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) as per below:
1. Carmustine (3.3 mg/ml) — 30.4
2. Cisplatin (1.0 mg/ml) — > 240
3. Cyclophosphamide (Cytoxan) (20.0 mg/ml) — > 240
4. Dacarbazine (10.0 mg/ml) — > 240
5. Doxomubixin Hydrochloride (2.0 mg/ml) — > 240
6. Etoposide (Toposar) (20.0 mg/ml) — > 240
7. Fluorouracil (50.0 mg/ml) — > 240
8. Methotrexate (25.0 mg/ml) — > 240
9. Mitomycin C (0.5 mg/ml) — > 240
10. Paclitaxel (6.0 mg/ml) — > 240
11. Thiotepa (10.0 mg/ml) — 15.6
12. Vincristine Sulfate (1.0 mg/ml) — > 240
Please note that the following drugs have extremely low permeation times of 30.4 minutes with Carmustine (3.3 mg/ml) and 15.6 minutes with Thiotepa (10.0 mg/ml)
The Nitrile Powder Free Examination Gloves (VIO - Violet) Tested for Use with Chemotherapy Drugs is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) as per below:
1. Carmustine (3.3 mg/ml) — 0.6
2. Cisplatin (1.0 mg/ml) — > 240
3. Cyclophosphamide (Cytoxan) (20.0 mg/ml) — > 240
4. Dacarbazine (10.0 mg/ml) — > 240
5. Doxorubixin Hydrochloride (2.0 mg/ml) — > 240
6. Etoposide (Toposar) (20.0 mg/ml) — > 240
7. Fluorouracil (50.0 mg/ml) — > 240
8. Methotrexate (25.0 mg/ml) — > 240
9. Mitomycin C (0.5 mg/ml) — > 240
10. Paclitaxel (6.0 mg/ml) — > 240
11. Thiotepa (10.0 mg/ml) — 46.7
12. Vincristine Sulfate (1.0 mg/ml) — > 240
Please note that the following drugs have extremely low permeation times of 0.6 minutes with Carmustine (3.3 mg/ml) and 46.7 minutes with Thiotepa (10.0 mg/ml)
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K120336 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120336: Nitrile Powder Free Examination Gloves (Vio) Tested for Use with Chenitrile Powder Free Examination (Ablu) Tested for U.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120336
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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