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Found 4 results
510(k) Data Aggregation
K Number
K110960Device Name
ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE
Manufacturer
KOON SENG SDN.BHD
Date Cleared
2011-07-14
(100 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
KOON SENG SDN.BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue is a single-use 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
The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue is a class I medical device classified under Product Code LZA. It is a single-use disposable device that meets all requirements of ASTM D 6319-10.
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K Number
K093375Device Name
KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)
Manufacturer
KOON SENG SDN.BHD
Date Cleared
2009-12-02
(34 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
KOON SENG SDN.BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Device Description
Powder free Latex Examination Glove is a class I device having product code LYY. It is a disposable device that meets all requirements of ASTM D3578-05.
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K Number
K013537Device Name
ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Manufacturer
KOON SENG SDN.BHD
Date Cleared
2001-12-07
(45 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
KOON SENG SDN.BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pre-Powdered Patient Examination Gloves is a disposable device which is primarily intended for medical purpose worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Device Description
ROYAL IMPERIAL LATEX Pre-Powdered Patient Examination Gloves WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
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K Number
K012714Device Name
ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
Manufacturer
KOON SENG SDN.BHD
Date Cleared
2001-10-31
(78 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
KOON SENG SDN.BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Powder Free Polymer Coated Patient Examination Gloves are disposable device which is primarily intended for medical purpose worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Device Description
Powder Free Polymer Coated Patient Examination Gloves
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