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510(k) Data Aggregation
K Number
K101594Device Name
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
Manufacturer
Date Cleared
2010-10-08
(122 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BETTER CARE PLASTIC TECHNOLOGY CP., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
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K Number
K101595Device Name
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
Manufacturer
Date Cleared
2010-08-06
(59 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BETTER CARE PLASTIC TECHNOLOGY CP., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
Ask a Question
Ask a specific question about this device
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