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510(k) Data Aggregation
K Number
K192111Device Name
Biodegradable Nitrile Examination Powder Free Glove, Green
Manufacturer
Top Glove SDN BHD
Date Cleared
2020-09-03
(395 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Top Glove SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biodegradable Nitrile Examination Powder Free Glove, Green is a non-sterile disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Biodegradable Nitrile Examination Powder Free Glove, Green
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K Number
K193150Device Name
Latex Examination Powder Free Glove, Aloe Vera
Manufacturer
Top Glove SDN BHD
Date Cleared
2020-06-05
(205 days)
Product Code
LZA, LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Top Glove SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is disposable glove intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Not Found
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K Number
K171279Device Name
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves
Manufacturer
Top Glove SDN BHD
Date Cleared
2017-10-12
(164 days)
Product Code
KGO, LZA, LZC
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Top Glove SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient. These gloves are tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Sterile Latex Surgical Powder Free Gloves is to be worn on the hands of healthcare professionals during surgery to prevent cross contamination between healthcare personnel and the patient.
Device Description
Not Found
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