Search Results
Found 1 results
510(k) Data Aggregation
K Number
K211624Device Name
USA Gloves Nitrile Powder Free Exam Gloves
Manufacturer
Date Cleared
2021-12-18
(205 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
USA Gloves
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
USA Gloves Nitrile Gloves and aforementioned predicate device are Non-powdered patient examination glove, as defined in 21 CFR 880.6250. Former Release Powder or Chemical: No release powder or chemical is used. USA Gloves Nitrile Gloves is not intended to be sterilized. The device is delivered in packaging which may be used as a protective carrying case.
Ask a Question
Ask a specific question about this device
Page 1 of 1