510(k) · Cleared
ClearedSterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grand Work Plastic Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on May 26, 2022 as substantially equivalent to K201531 (Hartalega Sdn Bhd, 2020) after a 115-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- May 26, 2022
- Review
- 115 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K201531 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backK201531 Sterile Nitrile Powder Free Examination Glove Tested for Use with…Hartalega Sdn Bhd · 2020
- This deviceK220249 Sterile Nitrile Powder Free Examination Gloves Tested For Use With…Grand Work Plastic Products Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy… | Hartalega Sdn Bhd | 2020 | — |
| 0 (this device) | K220249 | Sterile Nitrile Powder Free Examination Gloves Tested For Use With… | Grand Work Plastic Products Co., Ltd. | 2022 | — |
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 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? (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 |
|---|---|---|---|
| * | K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and…Summary page 5…I 3. Predicate Device Information: Hartalega SDN.BHD. Sterile Nitrile Powder Free Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K201531) 4. Device Description: The subject device is Sterile Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Dr… | 2020 |
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 no recall.
- 1 other device also cites its predicate K201531.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
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. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978 standards.
Gloves is direct contact and not to be worn for more than 24 hours
* Please note that the following drugs have extremely low permeation times:
Carmustine: 22.4 minutes, Thiotepa: 46.3 minutes
WARNING: DO NOT USE WITH CARMUSTINE
WARNING: DO NOT USE WITH THIOTEPA
Fentanyl Citrate Injection (100 mcg/2ml) >240
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220249: Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220249
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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