510(k) · Cleared
ClearedPink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test 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 Apr 9, 2022 as substantially equivalent to K192954 (Comfort Rubber Gloves Industries Sdn. Bhd., 2020) after a 57-day review. Its family tree reaches back 2 generations to 2019.
- Decided
- Apr 9, 2022
- Review
- 57 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K183287 (2019). No later device cites it as a predicate yet.
- 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 deviceK220401 Pink Powder Free Nitrile Examination Glove With Bubblegum Scented…Riverstone Resources Sdn Bhd · 2022
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) | K220401 | Pink Powder Free Nitrile Examination Glove With Bubblegum Scented… | Riverstone Resources Sdn Bhd | 2022 | — |
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 6…gally Marketed Device: Reference Device: K991744, SMART SHIELD POWDER FREE COLORED NITRILE EXAMINATION GLOVES WITH BUBBLE GUM SCENT Predicate Device: K192954 BLUE COLORED, POWDER FREE NITRILE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL CITRATE. 5.0… | 2020 |
| † | K991744 | Smart Shield Non-Sterile Powder-Free, Blue Nitrile Examination Gloves with Bubblegum Scent | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 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?
Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim is a disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use. In addition, these gloves were tested for use with Chemotherapy drug and Fentanyl test claim in accordance with ASTM D6978-05 standards. Practice for assessment of…
Read the full statement (179 words)
Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim is a disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use.
In addition, these gloves were tested for use with Chemotherapy drug and Fentanyl test claim in accordance with ASTM D6978-05 standards. Practice for assessment of Medical Glove to Permeation by chemotherapy drug and Fentanyl test claim
Chemotherapy Drugs and Concentration Minimum Breakthrough Detection Time (Min), ug/cm2/minute
1) Carmustine (BCNU) 3.3mg/ml 13.7 minutes
2) Cyclophosphamide (Cytoxan) (20mg/ml) >240 minutes
3) Cytarabine HCI (100mg/ml) >240 minutes
4) Doxorubicin HCI (2.0mg/ml) >240 minutes
5) Etoposide (20.Omg/ml >240 minutes
6) Fluorouracil (50.Omg/ml) >240 minutes
7) Methotrexate (25mg/mi) >240 minutes
8) Paclitaxel (6.Omg/ml) >240 minutes
9) ThioTepa (10.Omg/ml) 34.8 minutes
10) Fentanyl Citrate Injection 100mg/2ml >240 minutes
The Maximum testing time is 240 minutes. Please note that the following drugs have extremely low Permeation time,
Carmustine (BCNU) 3.3mg/ml
ThioTeta (10.Omg/ml)
Warning to do not use with Carmustine and Thio Tepa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220401 · printed Nov 3, 2026
Cite this page
510(k) Report. “K220401: Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K220401
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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