Search Results
Found 1 results
510(k) Data Aggregation
K Number
K112743Device Name
SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL
Manufacturer
Date Cleared
2011-12-16
(86 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
CLEAN MEDICAL MANFACTURING 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.
Ask a Question
Ask a specific question about this device
Page 1 of 1