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510(k) Data Aggregation
K Number
K211810Device Name
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)
Manufacturer
Date Cleared
2022-05-23
(346 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. Shamrock Manufacturing Corpora
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl.
Device Description
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners as a barrier protection to prevent contamination between a patient and an examiner. The qloves are powder free, ambidextrous, blue color, and beaded cuff.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The gloves are also complied with requirements for Standard Practice for Assessment of resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl as per ASTM D6978-05 (Reapproved 2019).
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