510(k) · Cleared
ClearedNon-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
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 Mar 25, 2023 after a 386-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 25, 2023
- Review
- 386 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. 2023, 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 Nitrile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient. This glove has also been tested for use with Chemotherapy Drugs. Tested Chemotherapy Drug and Concentration Min Breakthrough Detection Time (minutes) Carboplatin, 10 mg/ml >240 Carmustine, 3.3 mg/ml 15.0 Cisplatin (BCNU), 1.0 mg/ml >240 Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 Dacarbazine (DTIC), 10.0 mg/ml >240…
Read the full statement (140 words)
A Nitrile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient. This glove has also been tested for use with Chemotherapy Drugs.
Tested Chemotherapy Drug and Concentration Min Breakthrough Detection Time (minutes)
Carboplatin, 10 mg/ml >240
Carmustine, 3.3 mg/ml 15.0
Cisplatin (BCNU), 1.0 mg/ml >240
Cyclophosphamide (Cytoxan), 20.0 mg/ml >240
Dacarbazine (DTIC), 10.0 mg/ml >240
Doxorubicin Hydrochloride, 2.0 m/ml >240
Etoposide (Toposar), 20.0 mg/ml >240
Fluorouracil, 5.0 mg/ml >240
Ifosfamide, 50.0 mg/ml >240
Methotrexate, 25 mg/ml >240
MitomycinC, 0.5mg/ml >240
Mitoxantrone, 2 mg/ml >240
Paclitaxel (Taxol), 6.0 mg/ml >240
ThioTEPA, 10.0 mg/ml 30.1
Vincristine Sulfate, 1.0 mg/ml >240
The following chemotherapy drugs and concentration have extremely low permeation time.
Carmustine (3.3 mg/ml): 15.0 minutes, Thiotepa (10.0 mg/ml): 30.1 minutes
WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K220644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220644: Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220644
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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