510(k) · Cleared
ClearedBPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meditech Gloves Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Apr 17, 2022 as substantially equivalent to K192954 (Comfort Rubber Gloves Industries Sdn. Bhd., 2020) after a 180-day review. Its family tree reaches back 2 generations to 2019. 3 later devices descend from it.
- Decided
- Apr 17, 2022
- Review
- 180 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K183287 (2019). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- 1 generation backK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- This deviceK213408 BPG ChemoPlus Nitrile Patient Examination Gloves, Powder FreeMeditech Gloves Sdn Bhd · 2022
- Descendant · cites it directly · 2 of its ownK230121 Nitrile Examination Gloves Powder Free Tested For Use With…Careglove Global Sdn. Bhd. · 2023
- Descendant · 2 generations on · 0 of its ownK250578 Nitrile Examination Gloves Powder Free Tested for Use With…Careglove Global Sdn. Bhd. · 2025
- Descendant · 2 generations on · 0 of its ownK232252 Nitrile Powder Free Examination Gloves Tested for Use with…Dehai (Shandong) Medical Gloves, Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K230121Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl…Careglove Global Sdn. Bhd. · 2023 · cites it directly2descendants
- K250578Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl…Careglove Global Sdn. Bhd. · 2025 · 2 generations on0descendants
- K232252Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and…Dehai (Shandong) Medical Gloves, Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| −1 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| 0 (this device) | K213408 | BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free | Meditech Gloves Sdn Bhd | 2022 | — |
| +1 | K230121 | Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs… | Careglove Global Sdn. Bhd. | 2023 | — |
| +2 | K250578 | Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs… | Careglove Global Sdn. Bhd. | 2025 | — |
| +2 | K232252 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs… | Dehai (Shandong) Medical Gloves, Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and FentanylSummary page 5…ored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 510(k) : K192954 Regulatory : Class I Product Code : LZA, LZC, QDO 4.0 Description of… | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230121 | Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl… | 2023 | 2 |
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 3 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K230121 (Careglove Global Sdn. Bhd., 2023) has gone furthest, with 2 descendants of its own.
- 10 other devices also cite its predicate K192954.
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?
A patient examination glove 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 and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time…
Read the full statement (239 words)
A patient examination glove 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 and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Minutes)
Azacitidine, 25mg/ml (25,000 ppm) >240mins
Bleomycin Sulphate 15mg/ml (15,000 ppm) >240mins
Carboplatin 10mg/ml (10,000 ppm) >240mins
Carmustine (BCNU) 3.3mg/ml (3300 ppm) 22.5mins
Cetuximab 2mg/ml (2000 ppm) >240mins
Cisplatin Img/ml (1000 ppm) >240mins
Cyclophosphamide (Cytoxan) 20mg/ml (20,000 ppm) >240mins
Dacarbazine 10mg/ml (10,000 ppm) >240mins
Docetaxel 10mg/ml (10,000 ppm) >240mins
Doxorubicin HCI 2mg/ml (2,000 ppm) >240mins
Ellence (Epirubicin) 2mg/ml (2,000 ppm) >240mins
Etoposide 20mg/ml (20,000 ppm) >240mins
Fluorouracil 50mg/ml (50,000 ppm) >240mins
Gemcitabine 38mg/ml (38,000 ppm) >240mins
Ifosfamide 50mg/ml (50,000 ppm) >240mins
Irinotecan 20mg/ml (20,000 ppm) >240mins
Methotrexate 25mg/ml (25,000ppm) >240mins
Mitomycin C 0.5mg/ml (500 ppm) >240mins
Mitoxantrone 2mg/ml (2,000 ppm) >240mins
Oxaliplatin 2mg/ml (2,000ppm) >240mins
Paclitaxel 6mg/ml (6,000 ppm) >240mins
Rituximab 10mg/ml (10,000 ppm) >240mins
Thio Tepa 10 mg/ml (10,000 ppm) 36.1 mins
Vincristine Sulfate 1mg/ml 1,000 ppm) >240mins
Vinorelbine 10mg/ml (10,000 ppm) >240mins
Tested for Fentanyl Citrate is as follows:
Fentanyl Citrate 100mcg/2ml ~ >240mins
Please note the following drugs have low permeation times
Camustine (BCNU) 3.3mg/ml 22.5mins
Thio Tepa 10mg/ml 36.1mins
Warning: Do not use these gloves with Camustine or Thio Tepa.
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/K213408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213408: BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213408
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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