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510(k) Data Aggregation
K Number
K210730Device Name
Nitrile Patient Examination Glove
Manufacturer
Date Cleared
2021-08-10
(152 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
American Performance Polymers, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder-free 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.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
The Nitrile Medical Examination Glove is a non-sterile, single-use, disposable glove intended for medical purposes to be worn on the hands of examiners to prevent contamination between an examiner and the patient. The gloves are made of nitrile butadiene rubber and are white-colored and powder-free. The gloves are offered in one version in a range of sizes: x-small, small, medium, large, and x-large.
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