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Found 4 results
510(k) Data Aggregation
K Number
K993183Device Name
POWDER FREE GLOVES (POLYMER COATED)
Manufacturer
Date Cleared
1999-11-19
(57 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PAN-CENTURY RUBBER PRODUCTS SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
POWDER-FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
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K Number
K993287Device Name
POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
Manufacturer
Date Cleared
1999-10-29
(28 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PAN-CENTURY RUBBER PRODUCTS SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
POWDER FREE ( SILICON COATED ) LATEX EXAMINATION GLOVES. WITH PROTEIN LABELING CLAIM (50 micrognam or less
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K Number
K981164Device Name
POWDER FREE CHLORINATED GLOVES-(TEXTURED)
Manufacturer
Date Cleared
1998-04-23
(23 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PAN-CENTURY RUBBER PRODUCTS SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A DISPOSAL DEVICE TO PREVENT CONTAMINATION BETWEEN THE PATIENT AND EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN THE PATIENT AND EXAMINER .
Device Description
POWDER FREE ( TEXTURED ) LATEX EXAMINATION GLOVES ATTH PROTETH LABELLING CLAIMS ( 50 MICROGRAMS OR LESS )
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K Number
K955241Device Name
HIGH RISK GLOVES
Manufacturer
Date Cleared
1996-05-28
(195 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PAN-CENTURY RUBBER PRODUCTS SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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