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510(k) Data Aggregation
K Number
K111012Device Name
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS)
Manufacturer
Date Cleared
2011-07-06
(85 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TRUE GLOVE FACTORY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent device in between patient and examiner.
Device Description
Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green)
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K Number
K110314Device Name
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED)
Manufacturer
Date Cleared
2011-05-10
(97 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TRUE GLOVE FACTORY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Vinyl examination glove, Powder Free, Clear (Non-Colored) is a non-sterile 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
Stretch Vinyl Examination Glove, Powder Free (Yellow/White/Clear (non-colored)
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