510(k) · Cleared
ClearedNitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riverstone Resources Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Dec 17, 2019 as substantially equivalent to K180452 (Riverstone Resources Sdn Bhd, 2018) after a 272-day review. Its family tree reaches back 5 generations to 2004. 2 later devices descend from it.
- Decided
- Dec 17, 2019
- Review
- 272 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042805 (2004). 8 ancestors in all. 2 later devices descend 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 backK180452 White Nitrile Examination Glove, Sterile with Chemotherapy Drugs ClaimRiverstone Resources Sdn Bhd · 2018
- This deviceK190725 Nitrile Examination Glove Sterile Tested for use with Chemotherapy…Riverstone Resources Sdn Bhd · 2019
- Descendant · cites it directly · 1 of its ownK220250 Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for…Grand Work Plastic Products Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK232039 Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for…Grand Work Plastic Products Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See all- K220250Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…Grand Work Plastic Products Co., Ltd. · 2022 · cites it directly1descendant
- K232039Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…Grand Work Plastic Products Co., Ltd. · 2023 · 2 generations on0descendants
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 | K180452 | White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim | Riverstone Resources Sdn Bhd | 2018 | — |
| 0 (this device) | K190725 | Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs… | Riverstone Resources Sdn Bhd | 2019 | — |
| +1 | K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Grand Work Plastic Products Co., Ltd. | 2022 | — |
| +2 | K232039 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Grand Work Plastic Products Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K180452 | White Nitrile Examination Glove, Sterile with Chemotherapy Drugs ClaimSummary page 5…, Selangor 510k No:K190725 4.0) Identification of The Legally Marketed Device: K180452, White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim 5.0 Device Description The subject device in t… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy… | 2022 | 1 |
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 15 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K220250 (Grand Work Plastic Products Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The Nitrile Examination gloves,is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards : Practice for assessment of medical Glove to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough detection time in Minutes…
Read the full statement (132 words)
The Nitrile Examination gloves,is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards : Practice for assessment of medical Glove to Permeation by Chemotherapy Drugs.
Chemotherapy Drug and Concentration Minimum Breakthrough detection time in Minutes
1) Carmustine (BCNU)(3.3mg/ml) 39 minutes
2) Cyclophosphamide (20mg/ml) > 240 minutes
3) Cisplatin (l.0mg/ml) > 240 minutes
4) Doxorubicin Hydrochloride (2.0mg/ml) > 240 minutes
5) Etoposide (20mg/ml) > 240 minutes
6) Fluorouracil (50mg/ml) > 240 minutes
7) Methorexate (25mg/ml) > 240 minutes
8) Paclitaxel (6mg/ml) > 240 minutes
9) Thiotepa (10mg/ml) 97.6 minutes
Caution:
Thiotepa (l0mg/ml),Breakthrough Detected at 97.6 Minutes
Carmustine (3.3mg/ml),Breakthrough Detected at 39 Minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190725: Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190725
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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