510(k) · Cleared
ClearedRhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rhino Health, Inc. · LZA Polymer Patient Examination Glove
Cleared on Feb 13, 2023 as substantially equivalent to K221082 (Rhino Health, Inc., 2022) after a 52-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Feb 13, 2023
- Review
- 52 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K000323 (2000). No later device cites it as a predicate yet.
- Root · 8 generations backK000323 Nitrile Patient Examination Glove (Blue Color) Powder Free, Non…Siam Sempermed Corp., Ltd. · 2000
- 7 generations backK060753 Non-Sterile, Powder Free Nitrile Examination Glove, Blue with…Siam Sempermed Corp., Ltd. · 2006
- 6 generations backK080520 Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer…Siam Sempermed Corp., Ltd. · 2008
- 5 generations backK083755 Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue…Siam Sempermed Corp., Ltd. · 2009
- 4 generations backK182241 Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for…Sri Trang Gloves (Thailand) Co., Ltd. · 2019
- 3 generations backK193581 Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with…Sri Trang Gloves (Thailand) Public Company Limited · 2020
- 2 generations backK203236 Rhino Health Non-Sterile, Powder-free Nitrile Exam GloveRhino Health, Inc. · 2021
- 1 generation backK221082 Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle…Rhino Health, Inc. · 2022
- This deviceK223859 Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color…Rhino Health, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000323 | Nitrile Patient Examination Glove (Blue Color) Powder Free, Non Sterile | Siam Sempermed Corp., Ltd. | 2000 | — |
| −7 | K060753 | Non-Sterile, Powder Free Nitrile Examination Glove, Blue with Polymer Coating… | Siam Sempermed Corp., Ltd. | 2006 | — |
| −6 | K080520 | Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with… | Siam Sempermed Corp., Ltd. | 2008 | — |
| −5 | K083755 | Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color… | Siam Sempermed Corp., Ltd. | 2009 | — |
| −4 | K182241 | Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with… | Sri Trang Gloves (Thailand) Co., Ltd. | 2019 | — |
| −3 | K193581 | Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy… | Sri Trang Gloves (Thailand) Public Company Limited | 2020 | — |
| −2 | K203236 | Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove | Rhino Health, Inc. | 2021 | — |
| −1 | K221082 | Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested… | Rhino Health, Inc. | 2022 | — |
| 0 (this device) | K223859 | Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for… | Rhino Health, Inc. | 2023 | — |
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 |
|---|---|---|---|
| * | K221082 | Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use…Summary page 4…Approval Number Date Rhino Health, Rhino Non-sterile Powder-Free Nitrile Exam K221082 November Inc Glove – Periwinkle Color Tested for Use with 30, 2022 Chemo… | 2022 |
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 23 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Rhino Non-Sterile Powder-Free Nitrile Exam Gloves - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are as follows: Chemotherapy Drug Concentration Minimum Breakthrough Detection Time Carmustine (BCNU) ( 3.3mg/mL 3,300 ppm) 14.2 Cisplatin (…
Read the full statement (155 words)
Rhino Non-Sterile Powder-Free Nitrile Exam Gloves - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are as follows:
Chemotherapy Drug Concentration Minimum Breakthrough Detection Time
Carmustine (BCNU) ( 3.3mg/mL 3,300 ppm) 14.2
Cisplatin ( 1.0 mg/mL 1,000 ppm) > 240
Cyclophosphamide (Cytoxan) (20 mg/mL 20,000 ppm) > 240
Dacarbazine (10 mg/mL 10,000 ppm) > 240
Doxorubicin Hydrochloride (2.0 mg/mL 2,000 ppm) > 240
Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) > 240
Flurouracil (50.0 mg/mL 50,000 ppm) > 240
Paclitaxel (Taxol) (6.0 mg/mL 6,000 ppm) > 240
Thiotepa (10.0 mg/mL 10,000 ppm) 43.2
Fentanyl Tested as Follows:
Fentanyl Citrate Injection (100 mcg/2mL) > 240
Note: Carmustine and Thiotepa have extremely low permeation times of 14.2 and 43.2 minutes respectively.
Warning: Do Not Use with Carmustine, Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223859: Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223859
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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