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510(k) Data Aggregation
K Number
K220232Device Name
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
Manufacturer
Date Cleared
2022-02-20
(24 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Megine Industries Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 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.
Device Description
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
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K Number
K211310Device Name
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)
Manufacturer
Date Cleared
2021-06-16
(47 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Megine Industries Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 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.
Device Description
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) are Class I patient examination gloves bearing the product code Nitrile - LZA (2 ICFR880.6250). AMADEX - Nitrile Powder Free Examnation Gloves Non-Sterile,(Blue, Black, Orange) meet all the requirements of ASTM standard D 6319-10 and FDA 21 CFR 880.6250. The AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) is single-use device to prevent contamination between patient and examiner.
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