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510(k) Data Aggregation
K Number
K052845Device Name
B-CARE POWDERED LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2005-12-16
(70 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
B-CARE INDUSTRIES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The B-Care Powdered Latex Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Not Found
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K Number
K051404Device Name
B-CARE POWDER FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2005-09-27
(119 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
B-CARE INDUSTRIES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The B-Care Powder Free, Latex Examination Gloves is a disposable device intended for medical purposes that is worn on examiner's hands or finger to prevent contamination between patient and examiner. (21 CFR 880.6250)
Device Description
B-Care Powder Free, Latex Examination Gloves
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