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510(k) Data Aggregation
K Number
K031580Device Name
NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE
Manufacturer
GREEN PROSPECT SDN BHD
Date Cleared
2003-07-25
(66 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GREEN PROSPECT SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Class 1 Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a and FDA Water leak test.
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K Number
K031581Device Name
NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE COLOR, WITH PROTEIN LABELING, CONTAINS 50 MICROG
Manufacturer
GREEN PROSPECT SDN BHD
Date Cleared
2003-07-24
(65 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GREEN PROSPECT SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 and FDA Water leak test.
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