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510(k) Data Aggregation
K Number
K223859Device Name
Rhino Non-sterile Powder-Free Nitrile Exam Glove Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl
Manufacturer
Date Cleared
2023-02-13
(52 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Rhino Health Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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:
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
Device Description
Rhino Non-sterile Powder-Free Nitrile Exam Glove - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in three sizes, extra small, small, and extra large. The color for all sizes is periwinkle. The model number is RHI-UNB5 with specific part sizes based on size as follows:
Glove Size | Part Numbers
---|---
XS | RHI-UNB5XS100BX1
S | RHI-UNB5S100BX1
XL | RHI-UNB5XL100BX1
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K Number
K221082Device Name
Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl
Manufacturer
Date Cleared
2022-11-30
(231 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Rhino Health Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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:<br>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
Device Description
Rhino Non-sterile Powder-Free Nitrile Exam Glove - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in two sizes, medium and large. The color for all sizes is periwinkle. The model number is RHI-UNB5 with specific part sizes based on size as follows:
| Glove Size | Part Numbers |
|------------|-----------------|
| M | RHI-UNB5M100BX1 |
| L | RHI-UNB5L100BX1 |
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