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510(k) Data Aggregation
K Number
K193121Device Name
GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
Manufacturer
ECO Medi Glove SDN BHD
Date Cleared
2020-03-20
(129 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ECO Medi Glove SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gen 2 Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs.
Device Description
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with claiming, this product contains Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
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K Number
K181066Device Name
Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims
Manufacturer
ECO Medi Glove Sdn Bhd
Date Cleared
2018-09-26
(156 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ECO Medi Glove Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs.
Device Description
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and nonsterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05 and Modified Draize 95 test.
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K Number
K161187Device Name
EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs
Manufacturer
ECO MEDI GLOVE SDN BHD
Date Cleared
2016-09-09
(135 days)
Product Code
LZA, LZC, NIT
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ECO MEDI GLOVE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free patient eaxmination 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 for use with chemotherapy drugs.In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Device Description
The subject device in this 510(k) Notification is EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue colour, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
The Blue Nitrile Medical Examination Gloves ,Powder Free, 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 (product Code LZA) and is used with chemotherapy drugs (Product code LZC). The subject device is substantially equivalent to the legally marketed Nitrile Medical Examination Gloves (product Code LZA and LZC).
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K Number
K141623Device Name
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM
Manufacturer
ECO MEDI GLOVE SDN BHD
Date Cleared
2014-10-07
(112 days)
Product Code
LZA, LZC, NIT
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ECO MEDI GLOVE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Powder Free Examination Glove is a disposable device intended for Medical Purpose that is worn on the examiner's hand of fingers to prevent contamination between patient and examiner and for use with Chemotherapy Drugs In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drugs
Device Description
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, powder free, with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue colour, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
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