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Found 5 results
510(k) Data Aggregation
K Number
K984615Device Name
POWDERED NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-02-17
(50 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHIVA MEDICARE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Examination glove (Nitrile) is a disposable device made of Nitrile Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Device Description
Class I Patient Examination Gloves ( Nitrile) 80LZA that meets all 'the requirements of ASTM D3578- 95.
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K Number
K984610Device Name
POWDER FREE NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-02-09
(42 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHIVA MEDICARE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nitrile Examination Gloves Powder free is a powder free disposable device made of Nitrile Latex intended for medical purpose, that is worn on the examiners hand or finger to prevent contamination between patient and Examiner.
Device Description
Class I Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements of ASTM D3578- 95.
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K Number
K982589Device Name
SURGEON'S GLOVE
Manufacturer
Date Cleared
1998-09-10
(48 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SHIVA MEDICARE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Surgeon's glove is a medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Class I Surgeon's Glove 79KGO powdered with Absorbable Dusting Powder that meets all 'the requirements of ASTM D3577.
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K Number
K982579Device Name
LATEX EXAMINATION GLOVES POWDER FREE
Manufacturer
Date Cleared
1998-08-11
(18 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHIVA MEDICARE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Latex examination glove (Powder free) is a Powder free device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Device Description
Class I Patient Examination Gloves Latex ( Powder free) 80LYY that meets all 'the requirements of ASTM D3578- 95.
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K Number
K982586Device Name
POWDER FREE SURGEONS GLOVE
Manufacturer
Date Cleared
1998-08-11
(18 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SHIVA MEDICARE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free Surgeon's glove is a sterile powder free medical device intended to be worn I oncer free bargen ersonnel to protect a surgical wound from contamination.
Device Description
Class I Powder free Surgical Glove 79KGO that meets all the requirements of ASTM D3577.
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