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510(k) Data Aggregation
K Number
K213325Device Name
Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs
Manufacturer
Anhui Xinyisheng Medical Technology Co., Ltd
Date Cleared
2022-01-28
(115 days)
Product Code
LZC, LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Anhui Xinyisheng Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with the following chemotherapy drug concentrations per ASTM 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 drug has low permeation times of less than 60 minutes: Carmustine (BCNU) 3.3 mg/ml (3.300 ppm), 23.9minutes; ThioTepa10.0 mg/ml (10,000 ppm),25.3 minutes. WARNING: Do not use Carmustine and Thiotepa
Device Description
Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
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