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510(k) Data Aggregation
K Number
K100963Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Date Cleared
2010-08-06
(121 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**HEBEI SHENZICHEN PLASTIC **& RUBBER PRODUCTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Vinyl Patient Examination Gloves, 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
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
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K Number
K100964Device Name
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Date Cleared
2010-07-16
(100 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**HEBEI SHENZICHEN PLASTIC **& RUBBER PRODUCTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a 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
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.
Ask a Question
Ask a specific question about this device
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