510(k) · Cleared
ClearedPowder Free Nitrile Patient Examination Gloves, Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrp Asia Pacific Sdn. Bhd. · LZC Medical Glove, Specialty
Cleared on Jul 31, 2009 as substantially equivalent to K002064 (Wrp Asia Pacific Sdn. Bhd., 2000) after a 255-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jul 31, 2009
- Review
- 255 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002064 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK002064 Comfit Chemo Plus Powder Free Blue Nitrile Examination Gloves, Non…Wrp Asia Pacific Sdn. Bhd. · 2000 · Recalled
- This deviceK083408 Powder Free Nitrile Patient Examination Gloves, Tested for Use with…Wrp Asia Pacific Sdn. Bhd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002064 | Comfit Chemo Plus Powder Free Blue Nitrile Examination Gloves, Non Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2000 | 7 |
| 0 (this device) | K083408 | Powder Free Nitrile Patient Examination Gloves, Tested for Use with… | Wrp Asia Pacific Sdn. Bhd. | 2009 | — |
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? (1)
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 |
|---|---|---|---|
| * | K002064 | Comfit Chemo Plus Powder Free Blue Nitrile Examination Gloves, Non Sterile (Tested for…Summary page 1…e Blue Nitrile Examination Gloves Non-Sterile (Tested For use With Chemotherapy Drug) Labeling Claim Regulatory Class I Product code: LYY 510(k): K002064 4.0 Description of The Device: Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemothe… | 2000 |
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?
- Its one ancestor 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. 2009, 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 free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows [Carmustine (BiCNU), Thio-Tepa, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide and Paclitaxel].
WARNING: DO NOT USE THESE GLOVES WITH THIO-TEPA
CAUTION: Testing showed an average breakthrough time of less than 60 minutes with Carmustine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083408 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083408: Powder Free Nitrile Patient Examination Gloves, Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083408
Report an extraction error
Are you the manufacturer?
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