Search Results
Found 1 results
510(k) Data Aggregation
K Number
K213678Device Name
Powder Free Blue Nitrile Examination Gloves
Manufacturer
Date Cleared
2022-03-22
(120 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Lienteh Technology Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Blue Nitrile Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
The nitrile rubber is watertight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for the medical properties. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319-19 and ASTM D5151-19. This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner.
Ask a Question
Ask a specific question about this device
Page 1 of 1