510(k) · Cleared
ClearedNitrile Exam Glove, Extended cuff, 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
Zhonghong Pulin Medical Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Oct 26, 2023 as substantially equivalent to K193555 (Ever Global (Vietnam) Enterprise Corp, 2020) after a 230-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- Oct 26, 2023
- Review
- 230 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K042805 (2004). 8 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 backK161422 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2016
- 3 generations backK171171 KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile…Koon Seng Sdn Bhd · 2018
- 2 generations backK190403 Disposable Powder Free Nitrile Examination Glove, White, Tested for…Ever Global (Vietnam) Enterprise Corporation · 2019
- 1 generation backK193555 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested…Ever Global (Vietnam) Enterprise Corp · 2020
- This deviceK230662 Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy…Zhonghong Pulin Medical 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 | K161422 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2016 | — |
| −3 | K171171 | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for… | Koon Seng Sdn Bhd | 2018 | — |
| −2 | K190403 | Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With… | Ever Global (Vietnam) Enterprise Corporation | 2019 | — |
| −1 | K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use… | Ever Global (Vietnam) Enterprise Corp | 2020 | — |
| 0 (this device) | K230662 | Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs… | Zhonghong Pulin Medical Products Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…Summary page 7…Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate 510(k) number: K193555 5.0 Indication for Use A patient examination gloves is a disposable device intended for medical… | 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?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K193555.
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?
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug — Concentration —…
Read the full statement (582 words)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug — Concentration — Breakthrough Detection Time (minutes)
Bendamustine HCI — 5 mg/ml (5,000 ppm) — > 240
Bleomycin Sulfate — 15 mg/ml (15,000 ppm) — > 240
Busulfan — 6 mg/ml(6,000 ppm) — > 240
Carboplatin — 10.0 mg/ml (10,000 ppm) — > 240
Carfilzomib — 2 mg/ml (2,000 ppm) — > 240
Carmustine — 3.3 mg/ml (3,300 ppm) — 21.1 (24.2,21.1,25.3)
Cetuximab — 2 mg/ml (2,000 ppm) — > 240
Cisplatin — 1 mg/ml (1000 ppm) — > 240
Cladribine — 1 mg/ml (1000 ppm) — > 240
Cyclophosphamide — 20 mg/ml (20.000 ppm) — > 240
Cytarabine(Cytosine) — 10 mg/ml(10,000 ppm) — > 240
Cytovene(Ganciclovir) — 10 mg/ml(10,000 ppm) — > 240
Dacarbazine — 10 mg/ml(10,000 ppm) — > 240
Daunorubicin HCI — 5 mg/ml (5,000 ppm) — > 240
Decitabine — 5 mg/ml(5,000 ppm) — > 240
Docetaxel — 10 mg/ml (10.000 ppm) — > 240
Doxorubicin HCI — 2 mg/ml (2,000 ppm) — > 240
Epirubicin HCI (Ellence) — 20 mg/ml (20,000 ppm) — > 240
Etoposide — 20 mg/ml (20,000 ppm) — > 240
Fludarabine — 25.0 mg/ml (25,000 ppm) — > 240
Fluorouracil — 50 mg/ml,(50,000 ppm) — > 240
Fulvestrant — 50 mg/ml(50,000 ppm) — > 240
Gemcitabine — 38 mg/ml (38,000 ppm) — > 240
Idarubicin HCL — 1.0 mg/ml (1,000 ppm) — > 240
Ifosfamide — 50 mg/ml (50,000 ppm) — > 240
Irinotecan HCI — 20 mg/ml (20,000 ppm) — > 240
Mechlorethamine HCI — 1 mg/ml(1,000 ppm) — > 240
Melphalan — 5 mg/ml(5000 ppm) — > 240
Methotrexate — 25 mg/ml (25,000 ppm) — > 240
Mitomycin C — 0.5 mg/ml (500 ppm) — > 240
Mitoxantrone HCL — 2 mg/ml (2,000 ppm) — > 240
Oxaliplatin — 5 mg/ml (5,000 ppm) — > 240
Paclitaxel — 6 mg/ml (6,000 ppm) — > 240
Paraplatin — 10 mg/ml (10,000 ppm) — > 240
Pemetrexed — 25 mg/ml (25,000 ppm) — > 240
Raltitrexed — 0.5 mg/ml (500 ppm) — > 240
Rituximab — 10 mg/mi (10,000 ppm) — > 240
Temsirolimus — 25 mg/ml (25,000 ppm) — > 240
Thiotepa — 10 mg/ml(10,000 ppm) — 74.9 (74.9, 96.7, 79.0)
Topotecan — 1 mg/ml (1,000 ppm) — > 240
Trisenox (Arsenic Trioxide) — 1 mg/ml (1,000 ppm) — > 240
Vinblastine, — 1 mg/ml (1,000 ppm) — > 240
Vincristine sulfate (Oncovin) — 1 g/ml (1,000 ppm) — > 240
Vinorelbine — 10 mg/ml(10,000 ppm) — > 240
Fentanyl Citrate and other Drugs — Concentration — Breakthrough Detection Time (minutes)
Chloroquine — 50 mg/m (50,000 ppm) — > 240
Cyclosporin A — 100.0 mg/ml (100,000 ppm) — > 240
MESNA — 100 mg/ml(100,000 ppm) — > 240
Retrovir — 10 mg/ml(10,000 ppm) — > 240
Triclosan — 3 mg/ml(3,000 ppm) — > 240
Zoledronic Acid — 1 mg/25ml (40 ppm) — > 240
Fentanyl Citrate Injection — 100mcg/2mL — > 240
Note: The maximum testing time is 240 minutes. And testing showed minimum breakthrough time of 21.1 minutes with Carmustine (3.3 mg/ml), 74.9 minutes with Thio Tepa (10 mg/ml).
Warning: Do not use with Carmustine and Thiotepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230662 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230662: Nitrile Exam Glove, Extended cuff, 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/K230662
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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