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510(k) Data Aggregation
K Number
K013262Device Name
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2002-01-22
(113 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GREAT GLOVE (THAILAND) CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The glove is disposable and intended for Medical purpose that is worn on the hand of healthcare and similar personnel to prevent contamination between the patient and the examiner.
Device Description
Polymer Coated Powderfree Latex Examination Gloves
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K Number
K013026Device Name
POWDERED LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2001-10-15
(35 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GREAT GLOVE (THAILAND) CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powdered Latex Examination Gloves are worn on the hands of health care and Formilar personnel to prevent contamination between health care personnel and the patient.
Device Description
Not Found
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