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510(k) Data Aggregation
K Number
K220353Device Name
Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs
Manufacturer
Niujian Technology Co., Ltd
Date Cleared
2022-03-31
(51 days)
Product Code
LZC, LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Niujian 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 examination 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) >240 min.
Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) >240 min.
Dacarbazine,10.0 mg/ml (10,000 ppm) >240 min.
Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) >240 min.
Etoposide, 20.0 mg/ml (20,000 ppm) >240 min.
Fluorouracil,50.0 mg/ml (50,000 ppm) >240 min.
Paclitaxel,6.0 mg/ml (6,000 ppm) >240 min.
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 38.7 min.
ThioTepa10.0 mg/ml (10,000 ppm), 56.9 min
Please note that the following drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 38.7minutes
ThioTepa10.0 mg/ml (10.000 ppm),56.9 minutes
WARNING: Do not use Carmustine and Thiotepa
Device Description
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K Number
K220354Device Name
Disposable Medical Synthetic Nitrile Examination Gloves
Manufacturer
Niujian Technology Co., Ltd
Date Cleared
2022-03-24
(44 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Niujian Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Medical Synthetic Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Disposable Medical Synthetic Nitrile Examination Gloves
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K Number
K210706Device Name
Nitrile Examination Gloves
Manufacturer
Niujian Technology Co., Ltd.
Date Cleared
2021-10-19
(223 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Niujian Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Device Description
Nitrile Examination Gloves are patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirements specifications for barrier protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. The subject device is powder free nitrile examination gloves. The subject device is in blue color.
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