510(k) · Cleared
ClearedWhite Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
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 Jun 12, 2018 as substantially equivalent to K161187 (Eco Medi Glove Sdn. Bhd., 2016) and 1 other predicate after a 112-day review. Its family tree reaches back 4 generations to 2004. 3 later devices descend from it.
- Decided
- Jun 12, 2018
- Review
- 112 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K042805 (2004). 7 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 3 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 2 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 1 generation backK161187 EMG Blue Nitrile Examination Gloves Powder Free with Tested for use…Eco Medi Glove Sdn. Bhd. · 2016
- This deviceK180452 White Nitrile Examination Glove, Sterile with Chemotherapy Drugs ClaimRiverstone Resources Sdn Bhd · 2018
- Descendant · cites it directly · 2 of its ownK190725 Nitrile Examination Glove Sterile Tested for use with Chemotherapy…Riverstone Resources Sdn Bhd · 2019
- Descendant · 2 generations on · 1 of its ownK220250 Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for…Grand Work Plastic Products Co., Ltd. · 2022
- Descendant · 3 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 3 of 3 · See all- K190725Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, WhiteRiverstone Resources Sdn Bhd · 2019 · cites it directly2descendants
- K220250Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…Grand Work Plastic Products Co., Ltd. · 2022 · 2 generations on1descendant
- K232039Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…Grand Work Plastic Products Co., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −3 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −2 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −1 | K161187 | EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with… | Eco Medi Glove Sdn. Bhd. | 2016 | — |
| 0 (this device) | K180452 | White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim | Riverstone Resources Sdn Bhd | 2018 | — |
| +1 | K190725 | Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs… | Riverstone Resources Sdn Bhd | 2019 | — |
| +2 | K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Grand Work Plastic Products Co., Ltd. | 2022 | — |
| +3 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K161187 | EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy…Summary page 5…510K No : K180452 4.0 Identification of The Legally Marketed Device : The Primary Predicate K161187, EMG Blue Nitrile Examination Gloves Powder Free With Tested for use with Chemotherapy Drugs, and K171093 Sterile Nitrile P… | 2016 |
| * | K171093 | Sterile Nitrile Patient Examination Gloves, PowderfreeSummary page 5…he Legally Marketed Device : The Primary Predicate K161187, EMG Blue Nitrile Examination Gloves Powder Free With Tested for use with Chemotherapy Drugs, and K171093 Sterile Nitrile Patient Examination Gloves, Powder Free. 5.0 Device Description The subject device in this 51… | 2017 |
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 |
|---|---|---|---|
| K190725 | Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White | 2019 | 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 14 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K190725 (Riverstone Resources Sdn Bhd, 2019) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K161187.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 White Nitrile Examination Glove,Sterile, is a disposable device intended for medical purposes that is worn on the examinerls 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 Drugs and Concentration Minimum Breakthrough detection…
Read the full statement (145 words)
The White Nitrile Examination Glove,Sterile, is a disposable device intended for medical purposes that is worn on the examinerls 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 Drugs and Concentration Minimum Breakthrough detection time in minutes,0.0 I pg/cm2/minute
Carmustine (BCNU)(3.3 mg/ml) 17.1 Minutes
Cyclophosphamide (20 mg/ml) > 240 Minutes
Cisplatin (1.0 mg/ml) > 240 Minutes
Dacarbazine (DTIC) (10 mg/ml) > 240 Minutes
Doxorubicin Hydrochloride (2.0 mg/ml) > 240 Minutes
Etoposide (20 mg/ml) > 240 Minutes
Fluorouracil (50 mg/ml) > 240 Minutes
Paclitaxel (6.0 mg/ml) > 240 Minutes
Thiotepa (10 mg/ml) 55.9 minutes
The Maximum testing time is 240 Minutes.Please note that the following drugs have extremely low permeartion time:
Carmustine (BCNU)(3.3mg/ml)
Thiotepa ( 10mg/ml)
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/K180452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180452: White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180452
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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