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510(k) Data Aggregation
K Number
K973902Device Name
VINYL PATIENT EXAMINATION GLOVES POWDERED
Manufacturer
EVERRISE GLOVE PRODUCTS CO., LTD.
Date Cleared
1997-11-18
(35 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
EVERRISE GLOVE PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250. Vinyl Patient Examination Glove, 80LYZ, Powdered with an absorbable dusting starch powder, USP, Class III. conform to all requirements of ASTM Standard D5250-92 and FDA 1000ml water leak test.
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K Number
K973998Device Name
VINYL PATIENT EXAMINATION GLOVES POWDER-FREE
Manufacturer
EVERRISE GLOVE PRODUCTS CO., LTD.
Date Cleared
1997-11-18
(28 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
EVERRISE GLOVE PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250
Viryl Patient Examination Glove, Power Free, 80LYZ
conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.
Ask a Question
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