510(k) Report

510(k) · Cleared

Cleared

Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs

K230662510(k) TraditionalCleared Oct 26, 2023230-day reviewClass I21 CFR 880.6250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

  1. Root · 7 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
  2. 6 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
  3. 5 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
  4. 4 generations backK161422 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2016
  5. 3 generations backK171171 KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile…Koon Seng Sdn Bhd · 2018
  6. 2 generations backK190403 Disposable Powder Free Nitrile Examination Glove, White, Tested for…Ever Global (Vietnam) Enterprise Corporation · 2019
  7. 1 generation backK193555 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested…Ever Global (Vietnam) Enterprise Corp · 2020
  8. 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

GenerationNumberDeviceApplicantDecidedRecalls
−7K042805Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-SterilePerusahaan Getah Asas Sdn. Bhd.2004—
−6K081089Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with…Kimberly-Clark Corp.2008—
−5K141982Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile…Wrp Asia Pacific Sdn. Bhd.2015—
−4K161422Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile…Wrp Asia Pacific Sdn. Bhd.2016—
−3K171171KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for…Koon Seng Sdn Bhd2018—
−2K190403Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With…Ever Global (Vietnam) Enterprise Corporation2019—
−1K193555Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use…Ever Global (Vietnam) Enterprise Corp2020—
0 (this device)K230662Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs…Zhonghong Pulin Medical Products Co., Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K230662, 2004–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K193555Disposable 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…
Ever Global (Vietnam) Enterprise Corp2020—

Also cleared against K193555: 1 other device →

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 devices

LZA 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

2007: 212008: 182009: 282010: 312011: 262012: 332013: 202014: 272015: 202016: 302017: 442018: 222019: 252020: 302021: 1392022: 1462023: 622024: 302025: 242026 (partial year): 15
2007high 146 (2022) · low 18 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZA

110in 2025

2007: 95 days median2008: 97 days median2009: 112 days median2010: 97 days median2011: 122 days median2012: 110 days median2013: 130 days median2014: 197 days median2015: 112 days median2016: 171 days median2017: 124 days median2018: 178 days median2019: 212 days median2020: 101 days median2021: 111 days median2022: 111 days median2023: 92 days median2024: 89 days median2025: 110 days median2026 (partial year): 103 days median
2007high 212 (2019) · low 89 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZA

3so far in 2026, the most since 2007

2015: 12016: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZA

73in 2025

2007: 72008: 22009: 122010: 122011: 92012: 112013: 102014: 82015: 122016: 252017: 42018: 32019: 212020: 42021: 202022: 192023: 242024: 762025: 73
2007high 76 (2024) · low 2 (2008)2025

MAUDE reports naming product code LZA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007219507
2008189702
200928112012
20103197012
20112612209
201233110011
201320130010
20142719708
201520112112
201630171125
20174412404
20182217803
201925212021
20203010104
2021139111020
2022146111019
20236292024
20243089076
202524110073
2026151033—

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.

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