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510(k) Data Aggregation
K Number
K210990Device Name
Non-sterile Powder Free Nitrile Examination Gloves
Manufacturer
Date Cleared
2021-11-22
(234 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Rubberex Alliance Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A non-sterile 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. The device is for over-the-counter use.
Device Description
The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove. The subject device is a patient examination glove made from nitrile compound, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19, standard specification for Nitrile Examination Gloves.
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