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510(k) Data Aggregation
K Number
K210944Device Name
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
Manufacturer
Harbour Health LLC
Date Cleared
2021-04-29
(30 days)
Product Code
LZA, LZC, OPJ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Harbour Health LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Cloves to Permeation by Chemotherapy Drugs.
Device Description
The Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) is a non-sterile, single use only, disposable examination glove intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are nitrile, powder free, and blue in color. They feature an ambidextrous design with textured fingertips, straight fingers, and a beaded cuff. The gloves are available in sizes small, medium, large, and extra-large, packaged in a chipboard box.
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