Search Results
Found 19 results
510(k) Data Aggregation
K Number
K993454Device Name
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
1999-12-03
(51 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SRI JOHANI SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient Examination Glove is a 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
Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim) 50
Ask a Question
Ask a specific question about this device
K Number
K993457Device Name
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS]
Manufacturer
Date Cleared
1999-12-02
(50 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SRI JOHANI SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.
Device Description
Powderfree Latex Examination Gloves (Protein Label Claim) C 50mcg of
Ask a Question
Ask a specific question about this device
K Number
K993458Device Name
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
Manufacturer
Date Cleared
1999-11-10
(28 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SRI JOHANI SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient Examination Glove is a 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
Powdered Latex Examination Gloves (Protein Trade Name: Label Claim) [150 Micrograms or Less]
Ask a Question
Ask a specific question about this device
K Number
K981039Device Name
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)
Manufacturer
Date Cleared
1998-04-21
(33 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SRI JOHANI SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Patient Examination Glove is a 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
Powderfree Green Nitrile Examination Gloves (Polymer Coated)
Ask a Question
Ask a specific question about this device
K Number
K980037Device Name
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
Manufacturer
Date Cleared
1998-02-09
(35 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SRI JOHANI SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Patient Examination Glove is a 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
Powderfree Green Latex Examination Gloves ( Polymer Coated )
Ask a Question
Ask a specific question about this device
K Number
K980038Device Name
POWDERFREE GREEN LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
1998-02-09
(35 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SRI JOHANI SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Patient Examination Glove is a 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
Powderfree Green Latex Examination Gloves
Ask a Question
Ask a specific question about this device
K Number
K980039Device Name
POWDERED GREEN LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
1998-02-09
(35 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SRI JOHANI SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Patient Examination Glove is a 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
Powdered Green Latex Examination Gloves
Ask a Question
Ask a specific question about this device
K Number
K974886Device Name
POWDERED GREEN NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
1998-01-30
(31 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SRI JOHANI SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Patient Examination Glove is a 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
Powdered Green Nitrile Examination Gloves
Ask a Question
Ask a specific question about this device
K Number
K974887Device Name
POWDERFREE GREEN NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
1998-01-29
(30 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SRI JOHANI SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Patient Examination Glove is a 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
Powderfree Green Nitrile Examination Gloves
Ask a Question
Ask a specific question about this device
K Number
K974183Device Name
POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)
Manufacturer
Date Cleared
1997-12-18
(42 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SRI JOHANI SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Patient Examination Glove is a disposable device intended to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Pouderfree Blue Nitrile Examination Gloves Polymer Coated
Ask a Question
Ask a specific question about this device
Page 1 of 2