# K203236: Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove

- Pathway: 510(k) (Traditional)
- Applicant: Rhino Health, Inc.
- Decided: Aug 16, 2021 after 286 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: 6 generations back to K000323 (2000). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193581: Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster, Sri Trang Gloves (Thailand) Public Company Limited (2020) Summary page 4.

## Most influential descendants
- K221082: Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl (2022), 1 descendant of its own
- K223859: Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl (2023), 0 descendants of its own

## Indications for use
Rhino Non-Sterile Powder-Free Nitrile Patient Exam Glove - Blue 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. Test Results Follow: Chemotherapy Drug Concentration Minimum Breakthrough Detection Time Carmustine (BCNU) 3.3mg/mL (3,300 ppm) 23.1 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) 24.9 Fentanyl Tested as Follows: Fentanyl Citrate Injection (100mcg/2mL) > 240 Note: Carmustine and Thiotepa have extremely low permeation times of 23.1 and 24.9minutes respectively. Warning: Do Not Use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K203236
Methodology: https://510kreport.com/methodology