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510(k) Data Aggregation
K Number
K221877Device Name
Powder-Free Nitrile Examination Glove, Non-Sterile
Manufacturer
Date Cleared
2022-07-23
(25 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GoodGloves Industries Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over-the-counter use and single use only. The Powder-Free Nitrile Examination Gloves, Non-Sterile (Blue) is made of Nitrile, a synthetic rubber copolymer of acrylonitrile and butadiene. The device does not incorporate powder for purpose other than manufacturing. The final finished glove includes only residual powder from manufacturing. The Powder-Free Nitrile Examination Gloves, Non-Sterile is finishing through polymer coating process. The device is provided non-sterile.
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