510(k) · Cleared
ClearedDermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrp Asia Pacific Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Oct 20, 2016 as substantially equivalent to K141982 (Wrp Asia Pacific Sdn. Bhd., 2015) after a 150-day review. Its family tree reaches back 3 generations to 2004. 9 later devices descend from it.
- Decided
- Oct 20, 2016
- Review
- 150 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042805 (2004). 4 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 2 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 1 generation backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- This deviceK161422 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2016
- Descendant · cites it directly · 5 of its ownK171171 KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile…Koon Seng Sdn Bhd · 2018
- Descendant · 2 generations on · 4 of its ownK190403 Disposable Powder Free Nitrile Examination Glove, White, Tested for…Ever Global (Vietnam) Enterprise Corporation · 2019
- Descendant · 3 generations on · 3 of its ownK193555 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested…Ever Global (Vietnam) Enterprise Corp · 2020
- Descendant · 4 generations on · 1 of its ownK244034 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested…Ever Global (Vietnam) Enterprise Corporation · 2025
- Descendant · cites it directly · 1 of its ownK214110 Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile…Mah Sing Healthcare Sdn. Bhd. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K171171KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with…Koon Seng Sdn Bhd · 2018 · cites it directly5descendants
- K190403Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With…Ever Global (Vietnam) Enterprise Corporation · 2019 · 2 generations on4descendants
- K193555Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…Ever Global (Vietnam) Enterprise Corp · 2020 · 3 generations on3descendants
- K244034Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With…Ever Global (Vietnam) Enterprise Corporation · 2025 · 4 generations on1descendant
- K214110Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With…Mah Sing Healthcare Sdn. Bhd. · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −2 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −1 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| 0 (this device) | K161422 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2016 | — |
| +1 | 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 | — |
| +3 | K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use… | Ever Global (Vietnam) Enterprise Corp | 2020 | — |
| +4 | K244034 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use… | Ever Global (Vietnam) Enterprise Corporation | 2025 | — |
| +1 | K214110 | Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For… | Mah Sing Healthcare Sdn. Bhd. | 2022 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for…Summary page 5…Gloves, Non-sterile, Tested for use with Chemotherapy Drugs (and various brandnames) 510(k) Number K141982 MDL D236305 Regulatory Class I Product Code LZC, LZA 4.0 Description of Th… | 2015 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171171 | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with… | 2018 | 5 |
| K214110 | Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With… | 2022 | 1 |
| K232538 | Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested for Use with… | 2023 | 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 12 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K171171 (Koon Seng Sdn Bhd, 2018) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K141982.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Permeation The following chemicals have been tested with these gloves. Chemotherapy Drug…
Read the full statement (156 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 as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes
Flourouracil (Adrucil) 50.0mg/ml > 240
Etopside (Toposar) 20.0mg/ml >240
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
*Carmustine (BCNU) 3.3mg/ml 15.0
*Thiotepa 10.0mg/ml 2.0
Paclitaxel (Taxol) 6.0mg/ml > 240
Doxorubicin Hydrochloride (Adriamycin) 2.0mg/ml > 240
Dacarbazine 10.0mg/ml > 240
Cisplatin 1.0mg/ml > 240
Ifosfamide 50.0mg/ml > 240
Mitoxantrone 2.0mg/ml > 240
Vincristine Sulfate 1.0mg/ml > 240
Methotrexate 25mg/ml > 240
Mitomycin C 0.5mg/ml > 240
* Please note that the-following drugs have extremely low permeation times:
Carmustine (BCNU) : 15 minutes and Thiotepa : 2 minutes
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/K161422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161422: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161422
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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