510(k) · Cleared
ClearedSterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
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 Aug 9, 2023 as substantially equivalent to K220250 (Grand Work Plastic Products Co., Ltd., 2022) after a 30-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- Aug 9, 2023
- Review
- 30 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K042805 (2004). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 6 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 5 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 4 generations backK161187 EMG Blue Nitrile Examination Gloves Powder Free with Tested for use…Eco Medi Glove Sdn. Bhd. · 2016
- 3 generations backK180452 White Nitrile Examination Glove, Sterile with Chemotherapy Drugs ClaimRiverstone Resources Sdn Bhd · 2018
- 2 generations backK190725 Nitrile Examination Glove Sterile Tested for use with Chemotherapy…Riverstone Resources Sdn Bhd · 2019
- 1 generation backK220250 Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for…Grand Work Plastic Products Co., Ltd. · 2022
- This deviceK232039 Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for…Grand Work Plastic Products Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −6 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −5 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −4 | K161187 | EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with… | Eco Medi Glove Sdn. Bhd. | 2016 | — |
| −3 | K180452 | White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim | Riverstone Resources Sdn Bhd | 2018 | — |
| −2 | K190725 | Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs… | Riverstone Resources Sdn Bhd | 2019 | — |
| −1 | K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Grand Work Plastic Products Co., Ltd. | 2022 | — |
| 0 (this device) | K232039 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Grand Work Plastic Products Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
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 |
|---|---|---|---|
| * | K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…Summary page 6…I Predicate Device Information: Grand Work Plastic Products Co., Ltd. Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs (K220250) Classification Panel: 880 General Hospital and Personal Use Product Code: LZA, LZC Device Class: Class I Device Description… | 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?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- None of the 10 ancestors has a 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?
The glove is disposable device intended for medical purpose 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 and fentanyl citrate in accordance with ASTM D6978. Chemotherapy Drug Minimum BDT (Minutes) Carmustine (BCNU) (3.3mg/ml) 54.3 Cyclophosphamide (20mg/ml) >240 Doxorubicin Hydrochloride (2 mg/ml) >240 Etoposide (20mg/ml) >240…
Read the full statement (134 words)
The glove is disposable device intended for medical purpose 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 and fentanyl citrate in accordance with ASTM D6978.
Chemotherapy Drug Minimum BDT (Minutes)
Carmustine (BCNU) (3.3mg/ml) 54.3
Cyclophosphamide (20mg/ml) >240
Doxorubicin Hydrochloride (2 mg/ml) >240
Etoposide (20mg/ml) >240
Fluorouracil (50mg/ml) >240
Paclitaxel (6mg/ml) >240
Thiotepa (10mg/ml) 196.7
Methotrexate (25mg/ml) >240
Cisplatin (1mg/ml) >240
Vincristine Sulfate (1.0 mg/ml) >240
Cytarabine HCL (100mg/ml) >240
Mitoxantrone (2.0 mg/ml) >240
Mitomycin C (0.5 mg/ml) >240
Ifosfamide (50.0 mg/ml) >240
Dacarbazine (DTIC) (10.0 mg/ml) >240
Opioid Drug Minimum BDT (Minutes)
Fentanyl Citrate Injection (100mcg/2mL) >240
Caution: Please note that the following drugs have low permeation times:
Carmustine (BCNU): 54.3 minutes, Thiotepa: 196.7 minutes
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232039: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232039
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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