510(k) · Cleared
ClearedPowder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs
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 Dec 15, 2022 as substantially equivalent to K203036 (Central Medicare Sdn Bhd, 2021) after an 83-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Dec 15, 2022
- Review
- 83 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K203036 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backK203036 Non Sterile Powder Free Polyurethane Examination Gloves (Blue and…Central Medicare Sdn Bhd · 2021
- This deviceK222892 Powder Free Polyurethane Examination Gloves, Blue color, Tested for…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 | K203036 | Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) | Central Medicare Sdn Bhd | 2021 | — |
| 0 (this device) | K222892 | Powder Free Polyurethane Examination Gloves, Blue color, 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 |
|---|---|---|---|
| * | K203036 | Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)Summary page 4…, OPJ Device Class: Class I 3. Predicate Device Information: Central Medicare Sdn Bhd. Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)- (K203036) Reference device: Inner Mongolia Cureguard Medical Technology Co.,Ltd. Disposable Nitrile Examination Glove (Tested for use wit… | 2021 |
| † | K222642 | Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) | 2022 |
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.
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?
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05(2019) Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes Carmustine 3.3 mg/ml (3,300 ppm) 24.0 Cisplatin 1mg/ml (1,000 ppm) >240 Cyclophosphamide 20mg/ml (20,000 ppm) >240 Dacarbazine 10 mg/ml (10,000 ppm)…
Read the full statement (122 words)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05(2019)
Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes
Carmustine 3.3 mg/ml (3,300 ppm) 24.0
Cisplatin 1mg/ml (1,000 ppm) >240
Cyclophosphamide 20mg/ml (20,000 ppm) >240
Dacarbazine 10 mg/ml (10,000 ppm) >240
Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240
Etoposide, 20 mg/ml (20,000 ppm) >240
Fluorouracil, 50mg/ml (50,000ppm) >240
Methotrexate, 25mg/ml (25,000ppm) >240
Paclitaxel, 6mg/ml (6,000ppm) >240
Thiotepa, 10mg/ml (10,000ppm) 0.6
* Please note that the following drugs have extremely low permeation times:
Carmustine: 24.0 minutes, Thiotepa: 0.6 minutes
Warning: Do not use with Carmustine or Thiotepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222892: Powder Free Polyurethane Examination Gloves, Blue color, 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/K222892
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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