510(k) · Cleared
ClearedPowder Free Nitrle Examination Gloves with Chemotherapy Labeling Claim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Latexx Manufacturing Sdn.Bhd. · LZC Medical Glove, Specialty
Cleared on Mar 14, 2012 as substantially equivalent to K032444 (Cardinalhealth, 2003) and 1 other predicate after a 590-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Mar 14, 2012
- Review
- 590 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K022765 (2002). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK022765 Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp. · 2002
- This deviceK102189 Powder Free Nitrle Examination Gloves with Chemotherapy Labeling ClaimLatexx Manufacturing Sdn.Bhd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022765 | Nitrile Powder-Free Examination Gloves | Allegiance Healthcare Corp. | 2002 | — |
| 0 (this device) | K102189 | Powder Free Nitrle Examination Gloves with Chemotherapy Labeling Claim | Latexx Manufacturing Sdn.Bhd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032444 | Nitrile Powder-Free Examination Gloves with Lotion Coating and Use for ChemotherapySummary page 1…ch Equivalence is being Claimed: Primary Predicate: Cardinal Health Esteem Tru-Blu Stretchy Nitrite Exam Gloves 510(k) Number: K032444 Additional Predicate: Powder-Free Blue Nitrite Examination Gloves Tested for Use with Chemotherapy… | 2003 |
| * | K022765 | Nitrile Powder-Free Examination GlovesSummary page 1…nal Predicate: Powder-Free Blue Nitrite Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim 510(k) Number: K022765 4.0 Description of the Device: Powder-Free Nitrite Examination Gloves Tested for Use with Chemotherapy… | 2002 |
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.
What does this lineage say?
- None of the 2 ancestors has a 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 Powder Freea Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between examiner and patient In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as…
Read the full statement (188 words)
The Powder Freea Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between examiner and patient In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows:
Test Chemical and Concentration Average Breakthrough Detection Time (minutes)
Cisplatin, 1.0 mg/ml : 240
Cyclophosphamide (Cytoxan), 20.0 mg/mI : 240
Cytarabine, 100 mg/rn : 240
Cytovene, 10 mg/mI 240
Dacarbazine (OTIC), 10.0 mg/mI t 240
Docetaxel, 10.0 mg/mI , 4
Doxorubicin Hydrochloride, 2.0 mg/mI : 240
Fluorouracil, 50.0 mg/l t 240
Ifosfamide, 50.0 mg/mI : 240
Mechlorethamine HCI, 1.0 mglml 240
Methotrexate, 25 mg/ml 2t 240
Mitomycin C, 0.5 mg/mI 240
Mitoxantrone, 2 mg/mI 240
Oxaliplatin, Smq/mI 240
Paclitaxel (Taxol), 6.0 mg/mI 240
Vincristine Sulfate, 1.0 mg/mI 240
Vinorelbine, 10 mg/mi :240
Low Permeation Time (minutes) 1.7
Carmustine (BCNU), 3.3 mg/mI ___________________
Please note that the following drug has an extremely low permeation time:
Carmustine (8GNU) 1.7(mins)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102189: Powder Free Nitrle Examination Gloves with Chemotherapy Labeling Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102189
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026