510(k) · Cleared
ClearedPowder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anhui Intco Medical Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Jan 26, 2024 as substantially equivalent to K223713 (Better Care Plastic Technology Co., Ltd., 2023) after a 78-day review. Its family tree reaches back 4 generations to 2019.
- Decided
- Jan 26, 2024
- Review
- 78 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K183287 (2019). No later device cites it as a predicate yet.
- Root · 4 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 3 generations backK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- 2 generations backK221269 Powder Free Nitrile Examination Gloves (Blue),Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2022
- 1 generation backK223713 Powder Free Nitrile Examination Glove (Grey) Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2023
- This deviceK233598 Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile…Anhui Intco Medical Products Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −3 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| −2 | K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy… | Better Care Plastic Technology Co., Ltd. | 2022 | — |
| −1 | K223713 | Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy… | Better Care Plastic Technology Co., Ltd. | 2023 | — |
| 0 (this device) | K233598 | Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested… | Anhui Intco Medical Products Co., Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K223713 | Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and…Summary page 6…Device Information: Better Care Plastic Technology Co., Ltd. Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K223713) Product code LZA, LZC, QDO, OPJ. 4. Device Description: Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, a… | 2023 |
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 5 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 4 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. 2024, 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?
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs 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. These gloves were tested for use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs as per ASTM D6978-05 (Reapproved 2019) Standard…
Read the full statement (338 words)
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs 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.
These gloves were tested for use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Test Chemotherapy drug & Concentration Minimum Breakthrough Detection Times (Minutes)
Bendamustine HCI; 5 mg/ml >240
Bleomycin sulfate; 15 mg/ml >240
Busulfan ; 6 mg/ml >240
Carboplatin;10 mg/ml >240.
Carfilzomib; 2 mg/ml >240
Carmustine; 3.3 mg/ml 1.7
Cetuximab ; 2 mg/ml >240
Cisplatin; 1 mg/ml >240
Cladribine; 1 mg/ml >240
Cyclophosphamide; 20 mg/ml >240
Cytarabine ( Cytosine); 100 mg/ml >240
Cytovene (Ganciclovir); 10 mg/ml >240
Dacarbazine; 10 mg/ml >240
Daunorubicin HCL; 5 mg/ml >240
Decitabine; 5 mg/ml >240
Docetaxel; 20 mg/ml >240
Doxorubicin HCL; 2 mg/ml >240
Epirubicin HCL; 2 mg/ml >240
Etoposide; 20 mg/ml >240
Fludarabine Phosphate; 25 mg/ml >240
Fluorouracil; 50 mg/ml >240
Fulvestrant; 50 mg/ml >240
Gemcitabine HCI; 38 mg/ml >240
Idarubicin HCI; 1 mg/ml >240
Ifosfamide; 50 mg/ml >240
Irinotecan HCI ; 20 mg/ml >240
Mechlorethamine HCL; 1 mg/ml >240
Melphalan HCI; 5 mg/ml >240
Methotrexate ; 25 mg/ml >240
Mitomycin C; 0.5 mg/ml >240
Mitoxantrone HCI; 2 mg/ml >240
Oxaliplatin; 5 mg/ml >240
Pacilitaxel; 6 mg/ml >240
Pemetrexed; 25 mg/ml >240
Rituximab; 10 mg/ml >240
ThioTepa; 10 mg/ml 0
Topotecan HCL; 1 mg/ml >240
Trisonex; 1 mg/ml >240
Velcade (Bortezomib); 1 mg/ml >240
Vidaza (Azacytidine) ; 25 mg/ml >240
Vincrinstine Sulfate; 1 mg/ml >240
Vinorelbine Tartrate; 10 mg/ml >240
Zoledronic Acid; 0.8 mg/ml >240
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.7 minutes and
Thiotepa:0 minute
Warning: Do not use with Carmustine and Thiotepa
Fentanyl Citrate & Other Drugs Minimum Breakthrough Detection Times
Fentanyl Citrate Injection(100 mcg/2ml) >240
Chloroquine; 50mg/ml >240
Cyclosporin A; 100mg/mi >240
Retrovir; 10 mg/ml >240
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233598 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233598: Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233598
Report an extraction error
Are you the manufacturer?
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