510(k) · Cleared
ClearedNitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Careplus (M) Sdn Bhd · LZC Medical Glove, Specialty
Cleared on Jul 24, 2017 after a 285-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jul 24, 2017
- Review
- 285 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK162858 Nitrilecare Nitrile Examination Gloves Powder Free, Blue, ChemotestCareplus (M) Sdn Bhd · 2017
- Descendant · cites it directly · 0 of its ownK211666 Powder Free Nitrile Examination Gloves, Blue ChemotestCareglove Global Sdn. Bhd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K211666Powder Free Nitrile Examination Gloves, Blue ChemotestCareglove Global Sdn. Bhd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K162858 | Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest | Careplus (M) Sdn Bhd | 2017 | — |
| +1 | K211666 | Powder Free Nitrile Examination Gloves, Blue Chemotest | Careglove Global Sdn. Bhd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211666 | Powder Free Nitrile Examination Gloves, Blue Chemotest | 2022 | 0 |
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?
- Of its descendants, K211666 (Careglove Global Sdn. Bhd., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drugs Permeation The following chemicals have been tested with these gloves. Chemotherapy…
Read the full statement (132 words)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drugs Permeation
The following chemicals have been tested with these gloves.
Chemotherapy Concentration Minimum Breakthrough Detection Time (min)
Fluorouracil (Adrucil) 50.0mg/ml >240
Etopside(Toposar) 20.0mg/ml >240
Cyclophosphamide(Cytoxan) ~ 20.0mg/ml >240
*Carmustine(BCNU) 3.3mg/ml 10.2
*Thiotepa 10.0mg/ml 40.5
Paclitaxel(Taxol) 6.0mg/ml >240
Doxorubicin Hydrochloride(Adriamycin) 2.0mg/ml - >240
Dacarbazine 10.0mg/ml - >240
Cisplatin 1.0mg/ml >240
Ifosfamide 50.0mg/ml >240
Mitoxantrone 2.0mg/ml - >240
Vincristine Sulfate 1.0mg/ml >240
*Please note that following drugs have extremely low permeation times:
Carmustine (BCNU) :10.2 minutes and Thiotepa:40.5 minutes
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162858: Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162858
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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