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510(k) Data Aggregation
K Number
K220491Device Name
Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
Manufacturer
Hainan Asther Medical Equipment Co., Ltd
Date Cleared
2022-05-14
(81 days)
Product Code
LZC, LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hainan Asther Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for medical purpose that is worn on the examination between patient and examiner. In addition, these examination gloves were tested for use with the following chemotherapy drug concentrations per ASTN D6978-05(2019):
The following drugs had NO breakthrough detected up to 240 minutes:
Cisplatin, 1.0 mg/ml (1,000 ppm)
Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm)
Dacarbazine, 10.0 mg/ml (10,000 ppm)
Doxorubicin HCI, 2.0 mg/ml (2,000 ppm)
Etoposide, 20.0 mg/ml (20,000 ppm)
Fluorouracil, 50.0 mg/ml (50,000 ppm)
Paclitaxel, 6.0 mg/ml (6,000 ppm)
Please note that the following drugs have low permeation times of less than 240 minutes: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 34.4minutes ThioTepa10.0 mg/ml (10,000 ppm),88.5 minutes
WARNING: Do not use with Carmustine and Thiotepa
Device Description
Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
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