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510(k) Data Aggregation
K Number
K980093Device Name
DISPOSABLE SYNTHETIC PATIENT EXMINATION GLOVES, POWDER FREE
Manufacturer
UNIVERSAL GLOVES CORP.
Date Cleared
1998-03-02
(52 days)
Product Code
LYZ, FEB
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL GLOVES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purpose which is worn on examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
(1) Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250
(2) Vinyl Patient Examination Glove, Powder Free, 80LYZ
(3) conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.
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