510(k) · Cleared
ClearedPowderFree White Blue Sterilized Nitrile Copolymer 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
Smart Glove Corporation Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Jul 26, 2019 after a 245-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 26, 2019
- Review
- 245 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. 2019, 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 Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below. Chemotherapy Drug permeation and concentration ( Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves. Breakthrough Detection Time in Minutes Chemotherapy Drugs: White Glove…
Read the full statement (221 words)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Chemotherapy Drug permeation and concentration ( Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves.
Breakthrough Detection Time in Minutes
Chemotherapy Drugs: White Glove Blue Glove
1. Carmustine ( BCNU)3.3 mg/ml(3,300 ppm) 7.1 min 23.4 min
2. Cisplatin 1.0 mg/ml (l ,000ppm) >240 min >240 min
3. Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) >240 min >240 min
4. Dacarbazine (DTIC)l0.0 mg/ml(I0,000ppm) >240 min >240 min
5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) >240 min >240 min
6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) >240 min >240 min
7. Fluorouracil 50.0 mg/ml (50,000ppm) >240 min >240 min
8. lfosfamide 50.0 mg/ml (50,000ppm) >240 min >240 min
9. Methotrexate 25 mg/ml (25,000ppm) >240 min >240 min
10.Mitomycin C 0.5 mg/ml (500ppm) >240 min >240 min
11. Mitoxantrone 2.0 mg/ml (2,000ppm) >240 min >240 min
12. Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) >240 min >240 min
13. Thio-Tepa 10.0 mg/ml (10,000ppm) 78.6 min 39.3 min
14.Yincristine Sulfate 1.0 mg/ml ( l ,000ppm) >240 min >240 min
WARNING: Do not use with Carmustine or Thio-Tepa.
Please note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K183280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183280: PowderFree White Blue Sterilized Nitrile Copolymer 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/K183280
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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