510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pt. Maja Agung Latexindo · LZA Polymer Patient Examination Glove
Cleared on May 18, 2022 as substantially equivalent to K171339 (Eco Medi Glove Sdn. Bhd., 2017) after a 288-day review. Its family tree reaches back 5 generations to 2004. 1 later device descends from it.
- Decided
- May 18, 2022
- Review
- 288 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042805 (2004). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 4 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 3 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 2 generations backK161187 EMG Blue Nitrile Examination Gloves Powder Free with Tested for use…Eco Medi Glove Sdn. Bhd. · 2016
- 1 generation backK171339 EMG Blue Nitrile Examination Gloves Powder free with tested for use…Eco Medi Glove Sdn. Bhd. · 2017
- This deviceK212408 Powder Free Nitrile Examination Gloves (Tested for Use with…Pt. Maja Agung Latexindo · 2022
- Descendant · cites it directly · 0 of its ownK251716 Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy…Basic Medical Technology, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251716Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl…Basic Medical Technology, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −4 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −3 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −2 | K161187 | EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with… | Eco Medi Glove Sdn. Bhd. | 2016 | — |
| −1 | K171339 | EMG Blue Nitrile Examination Gloves Powder free with tested for use with… | Eco Medi Glove Sdn. Bhd. | 2017 | — |
| 0 (this device) | K212408 | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs… | Pt. Maja Agung Latexindo | 2022 | — |
| +1 | K251716 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid… | Basic Medical Technology, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K171339 | EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy…Summary page 5…Predicate: Device name: EMG Blue Nitrile Examination Gloves Powder free with tested for use with Chemotherapy Drugs Company: ECO Medi Glove Sdn. Bhd 510(k): K171339 Regulatory Class I Product Code: LZA, LZC 4) Device Description: The Powder Free Nitrile Examination Gloves, Blue Color,… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251716 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl… | 2025 | 0 |
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 18 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K251716 (Basic Medical Technology, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K171339.
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 purpose that is worn on examiner’s hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate. Chemotherapy Drug and Permeation The following chemicals have been tested…
Read the full statement (219 words)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner’s hand to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, Simulated Gastric Acid, and Fentanyl Citrate.
Chemotherapy Drug and Permeation
The following chemicals have been tested with these gloves:
Chemotherapy Drug and Concentration Breakthrough Detection Time in Minutes
Carboplatin (Paraplatin), 10 mg/ml (10,000ppm) > 240 min.
Carmustine (BCNU), 3.3 mg/ml (3,300ppm) 58.3 min (Not recommended for use)
Cisplatin, 1.0 mg/ml (1,000ppm) > 240 min
Cyclophosphamide (Cytoxan), 20.0mg/ml (20,000 ppm) > 240 min
Dacarbazine, 10.0mg/ml (10,000ppm) > 240 min
Docetaxel, 10mg/ml (10,000ppm) > 240 min
Doxorubicin HCI, 2.0mg/ml (2,000ppm) > 240 min
Etoposide, 20.0mg/ml (20,000ppm) > 240 min
Fluorouracil, 50.0mg/ml (50,000ppm) > 240 min
Ifosfamide, 50 mg/ml (50,000 ppm) > 240 min
Methotrexate, 25mg/ml (25,000 ppm) > 240 min
Mitomycin C, 0.5 mg/ml (500 ppm) > 240 min
Paclitaxel, 6.0 mg/ml (6,000 ppm) > 240 min
ThioTepa, 10.0mg/ml (10,000ppm) 119 min (Not recommended for use)
Vincristine Sulfate, 1 mg/ml (1,000 ppm) > 240 min
Simulated Gastric Acid > 240 min
Fentanyl Citrate Injection 100.0 mg/2ml > 240 min
WARNING: Do not use with Carmustine (BCNU) 3.3 mg/ml and Thiotepa (10mg/ml).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212408: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212408
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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