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510(k) Data Aggregation
K Number
K051393Device Name
DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
Manufacturer
Date Cleared
2005-07-27
(61 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
EVER GLOBAL ENTERPRISE CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00E4.
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K Number
K051498Device Name
DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR
Manufacturer
Date Cleared
2005-07-06
(29 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
EVER GLOBAL ENTERPRISE CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION between patient and EXAMINER.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ., and meets all requirements of ASTM Standard D5250-00E4.
Ask a Question
Ask a specific question about this device
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