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510(k) Data Aggregation
K Number
K213548Device Name
Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
Manufacturer
Date Cleared
2022-02-21
(105 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Mercator Medical (Thailand) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves Tested for use with Chemotherapy Drugs are disposable devices intended for medical propose that are worn on the examiner's hands to prevent contamination between patent and examiner.
The proposed device was tested for use with Chemotherapy Drugs as per ASTM D678-05 Standard Practice for Assessment Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drugs Permeation.
Device Description
Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves Tested for use with Chemotherapy Drugs are disposable devices intended for medical propose that are worn on the examiner's hands to prevent contamination between patent and examiner.
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K Number
K200967Device Name
mCare(R) Powder Free Nitrile Orange Examination Gloves
Manufacturer
Date Cleared
2020-06-06
(57 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Mercator Medical (Thailand) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
mCare® Powder Free Nitrile Orange Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
mCare® Powder Free Nitrile Orange Examination Gloves
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K Number
K192444Device Name
mCare® Powder Free Nitrile Black Examination Glove
Manufacturer
Date Cleared
2019-12-31
(116 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Mercator Medical (Thailand) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
mCare® Powder Free Nitrile Black Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
mCare® Powder Free Nitrile Black Examination Glove
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K Number
K190876Device Name
mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
Manufacturer
Date Cleared
2019-12-02
(242 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Mercator Medical (Thailand) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
mCare® Powder Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05, The following drugs had no breakthrough detected up to 240 minutes
- 1. Cisplatin, 1.0 mg/ml
- 2. Cyclophosphamide (Cytoxan), 20 mg/ml
- 3. Dacarbazine (DTIC), 10.0 mg/ml
- 4. Doxorubicin Hydrochloride, 2.0 mg/ml
- 5. Etoposide (Toposar), 20.0 mg/ml
- 6. Fluorouracil, 50.0 mg/ml
- 7. Methotrexate, 25 mg/ml
- 8. Mitomycin C,0.5 mg/ml
- 9. Paclitaxel (Taxol), 6.0 mg/ml
- 10. Vincristine 1.0 mg/ml
The following drugs showed breakthrough detected in less than 240 minutes:
- 1. Carmustine (BCNU), 3.3 mg/ml: 24.6 minutes
2. Thiotepa (THT) 10.0 mg/ml: 68.9 minutes
Warning-Not for Use with Carmustine and Thiotepa
Device Description
mCare® Powder-Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
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K Number
K172930Device Name
mCare Powder-free Blue Nitrile Examination Gloves
Manufacturer
Date Cleared
2018-04-13
(200 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Mercator Medical (Thailand) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
mCare® Powder Free Nitrile Blue Examination Glove are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
mCare® Powder-free Nitrile Blue Examination Gloves are substantially equivalent to the Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D 6319 -10, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
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K Number
K141042Device Name
MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
Manufacturer
Date Cleared
2015-03-19
(330 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MERCATOR MEDICAL (THAILAND) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The mCare Powder Free Latex Examination Blue Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
mCare Powder Free Latex Examination Blue Glove
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