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510(k) Data Aggregation
K Number
K023910Device Name
STERILE PATIENT POWDERFREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2003-02-11
(78 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SANREA HEALTHCARE PRIVATE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
An Examination glove is a disposable device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Device Description
POWDERFREE STERILE LATEX EXAMINATION GLOVES
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K Number
K023912Device Name
POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM
Manufacturer
Date Cleared
2003-02-11
(78 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SANREA HEALTHCARE PRIVATE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Surgeon's glove is a device made of natural nusber intended to be worn by operating room personnel to protect a surgicul wound from concamination.
Device Description
POWDERFREE LATEX SURGEON'S GLOVES . Cantains 50 megm on less of Total Water per gram protect
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K Number
K023915Device Name
STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2003-02-11
(78 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SANREA HEALTHCARE PRIVATE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
An Examination glove is a disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
STERILE PATIENT EXAMINATION GLOVES - POWDERFD
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K Number
K023515Device Name
PRE-POWDERED LATEX SURGEON'S GLOVES
Manufacturer
Date Cleared
2003-01-16
(87 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SANREA HEALTHCARE PRIVATE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination
Device Description
pre-POWDERED LATEX SURGEON'S GLOVES
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