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Found 4 results
510(k) Data Aggregation
K Number
K001274Device Name
LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2000-06-23
(64 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
P.T. MAJA AGUNG LATEXINDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K994255Device Name
LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE
Manufacturer
Date Cleared
2000-02-07
(52 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
P.T. MAJA AGUNG LATEXINDO
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 and patient examiners that require a sterile procedure.
A latex 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 examiners that require a sterile procedure.
Device Description
Not Found
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K Number
K992752Device Name
SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5
Manufacturer
Date Cleared
1999-11-05
(81 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
P.T. MAJA AGUNG LATEXINDO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A surgeon's glove is a disposable device intended for medical purpose that is worn on surgeon's hands during surgical operations to prevent contamination between patient surgeon's
Device Description
Latex Surgeon's Gloves Pre-Powdered Sterile
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K Number
K982897Device Name
POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
1998-12-23
(128 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
P.T. MAJA AGUNG LATEXINDO
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 examiner's hand or finger to prevent contamination between patient and examiners.
Device Description
Latex Examination Gloves Powder Free with Protein Claim
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