# K223859: Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl

- Pathway: 510(k) (Traditional)
- Applicant: Rhino Health, Inc.
- Decided: Feb 13, 2023 after 52 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K000323 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221082: Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl, Rhino Health, Inc. (2022) Summary page 4.

## Indications for use
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

Source page: https://510kreport.com/device/K223859
Methodology: https://510kreport.com/methodology