Search Results
Found 1 results
510(k) Data Aggregation
K Number
K142685Device Name
NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE
Manufacturer
Date Cleared
2015-02-11
(142 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SIAM SEMPERMED CORP., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner
Device Description
The subject device is a patient examination glove made of a synthetic nitrile latex compound. It is non-sterile, powder-free, with a polymer inner coating of aloe and Vitamin E (per 21 CFR 880.6250, Class I). The device can be either white or pink in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application.
Ask a Question
Ask a specific question about this device
Page 1 of 1