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510(k) Data Aggregation
K Number
K093797Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE)
Manufacturer
Date Cleared
2010-02-23
(75 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is 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
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 Classince by I DA's Gelleral Hoopication Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
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K Number
K093798Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
Manufacturer
Date Cleared
2010-02-23
(75 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUPERMAX PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is 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
Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
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Ask a specific question about this device
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