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510(k) Data Aggregation
K Number
K971102Device Name
AMBIDERM
Manufacturer
Date Cleared
1997-08-29
(156 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERTEX INDUSTRIAL, S.A. DE C.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes, that is worn on It pation oxamination grove is a sevent contamination between patient and examiner.
Device Description
Colored Ambiderm Powder-Free Examination Gloves with Protein Labeling Claim. (White, Violet, Green, Yellow, Orange, Pink & Blue) .
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K Number
K963866Device Name
AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN)
Manufacturer
Date Cleared
1997-02-10
(210 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERTEX INDUSTRIAL, S.A. DE C.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K962737Device Name
AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN)
Manufacturer
Date Cleared
1997-02-07
(207 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERTEX INDUSTRIAL, S.A. DE C.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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