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510(k) Data Aggregation
K Number
K213934Device Name
Pro Guard Nitrile Powder Free Examination Glove
Manufacturer
Date Cleared
2022-08-06
(233 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Medical Glove Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Pro Guard ® Nitrile Powder free 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.
Device Description
Black Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21 CFR 880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are black in color and are powder free.
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K Number
K213500Device Name
TMG Nitrile Powder Free Examination Glove
Manufacturer
Date Cleared
2022-02-21
(112 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Thai Medical Glove Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TMG nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
TMG Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
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